Deployments
What is actually cleared
Deployment status is a closed taxonomy, so a claim cannot be upgraded by enthusiasm. Announced is not deployed, a pilot is not a rollout, and a demonstration is neither. Every row below is a system a regulator has cleared, linked to the clearance itself.
Sunday, 4 October 2026 · 268 products across 286 companies
Cleared systems
Read from the database on each request · last verified 2026-08-07
| Product | Company | Segment | Status | First cleared | Confidence | Clearance |
|---|---|---|---|---|---|---|
| Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | Medical & surgical | Deployed | 2026-07-22 | High | 510(k) ↗ |
| OTTAVA Robotic Surgical System | Johnson & Johnson | Medical & surgical | Deployed | 2026-07-21 | High | 510(k) ↗ |
| OTTAVA Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | Medical & surgical | Deployed | 2026-07-21 | High | 510(k) ↗ |
| CORUS Navigation System-GN | Providence Medical Technology, Inc. | Medical & surgical | Deployed | 2026-06-18 | High | 510(k) ↗ |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation | Life Spine, Inc. | Medical & surgical | Deployed | 2026-06-02 | High | 510(k) ↗ |
| ROSA Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | Medical & surgical | Deployed | 2026-05-21 | High | 510(k) ↗ |
| Senhance Ultrasonic System | Asensus Surgical, Inc. | Medical & surgical | Deployed | 2026-05-12 | High | 510(k) ↗ |
| Robotic Surgical - Permanent Cautery Hook | Restore Robotics | Medical & surgical | Deployed | 2026-03-26 | High | 510(k) ↗ |
| Valence Robotic Navigation System | Alphatec Spine, Inc. | Medical & surgical | Deployed | 2026-02-19 | High | 510(k) ↗ |
| Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | Medical & surgical | Deployed | 2026-02-12 | High | 510(k) ↗ |
| ROSA Knee System with UltraSound Imaging Platform | Balmoral Medical, LLC | Medical & surgical | Deployed | 2026-02-06 | High | 510(k) ↗ |
| Navigation Module of the Cortium System | Ulrich Medical USA, Inc. | Medical & surgical | Deployed | 2026-02-03 | High | 510(k) ↗ |
| POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | Point Robotics MedTech, Inc. | Medical & surgical | Deployed | 2026-01-23 | High | 510(k) ↗ |
| DYNAMIS Navigation System | Promethean Restorative, LLC | Medical & surgical | Deployed | 2026-01-12 | High | 510(k) ↗ |
| Firebird SI Navigation System | Orthofix US, LLC | Medical & surgical | Deployed | 2025-10-31 | High | 510(k) ↗ |
| Yomi S Robotic System | Neocis, Inc. | Medical & surgical | Deployed | 2025-10-28 | High | 510(k) ↗ |
| OsteoCentric Navigated System | Osteocentric Technologies, Inc. | Medical & surgical | Deployed | 2025-10-27 | High | 510(k) ↗ |
| Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. | Medical & surgical | Deployed | 2025-09-11 | High | 510(k) ↗ |
| LIBERTY Endovascular Robotic System | Microbot Medical , Ltd. | Medical & surgical | Deployed | 2025-09-04 | High | 510(k) ↗ |
| CORUS Navigation System-GX | Providence Medical Technology, Inc. | Medical & surgical | Deployed | 2025-07-30 | High | 510(k) ↗ |
| da Vinci X Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2025-06-11 | High | 510(k) ↗ |
| Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II | Remex Medical Corporation | Medical & surgical | Deployed | 2025-05-29 | High | 510(k) ↗ |
| Altus Spine Navigation System | Altus Partners, LLC | Medical & surgical | Deployed | 2025-05-08 | High | 510(k) ↗ |
| Dynamis Robotic Surgical System | LEM Surgical AG | Medical & surgical | Deployed | 2025-04-23 | High | 510(k) ↗ |
| Medyssey Navigation System | Medyssey Co, Ltd. | Medical & surgical | Deployed | 2025-04-16 | High | 510(k) ↗ |
| Salvo Robotic Navigation | Spine Wave, Inc. | Medical & surgical | Deployed | 2025-04-03 | High | 510(k) ↗ |
| mBôs | Monogram Orthopaedics, Inc. | Medical & surgical | Deployed | 2025-03-14 | High | 510(k) ↗ |
| GYDER Hip System | Gyder Surgical Pty, Ltd. | Medical & surgical | Deployed | 2025-01-29 | High | 510(k) ↗ |
| NuVasive Pulse System | Globus Medical, Inc. | Medical & surgical | Deployed | 2025-01-10 | High | 510(k) ↗ |
| AnyPlus Navigated System | GS Medical Co., Ltd. | Medical & surgical | Deployed | 2024-12-06 | High | 510(k) ↗ |
| Q Guidance System | Stryker | Medical & surgical | Deployed | 2024-08-27 | High | 510(k) ↗ |
| Q Guidance System | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2024-08-27 | High | 510(k) ↗ |
| HYDROS Robotic System | Procept BioRobotics | Medical & surgical | Deployed | 2024-08-20 | High | 510(k) ↗ |
| HYDROS Robotic System | Procept Biorobotics, Corporation | Medical & surgical | Deployed | 2024-08-20 | High | 510(k) ↗ |
| Spine Navigation System | Medivis, Inc. | Medical & surgical | Deployed | 2024-07-26 | High | 510(k) ↗ |
| TMINI Miniature Robotic System | THINK Surgical, Inc. | Medical & surgical | Deployed | 2024-07-12 | High | 510(k) ↗ |
| da Vinci Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2024-07-03 | High | 510(k) ↗ |
| da Vinci Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2024-07-03 | High | 510(k) ↗ |
| Robotic Integration | DePuy Synthes | Medical & surgical | Deployed | 2024-06-17 | High | 510(k) ↗ |
| Spine Navigation and Robotic-Assistance Device | Ecential Robotics | Medical & surgical | Deployed | 2024-06-14 | High | 510(k) ↗ |
| TELIGEN System Navigation Ready | DePuy Synthes | Medical & surgical | Deployed | 2024-06-14 | High | 510(k) ↗ |
| Steriking Pouch for Robotic | Wipak OY | Medical & surgical | Deployed | 2024-06-07 | High | 510(k) ↗ |
| Spine Guidance | Stryker | Medical & surgical | Deployed | 2024-06-06 | High | 510(k) ↗ |
| Spine Guidance | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2024-06-06 | High | 510(k) ↗ |
| CORUS Navigation Access System | Providence Medical Technology, Inc. | Medical & surgical | Deployed | 2024-05-03 | High | 510(k) ↗ |
| Remex Spine Surgery Navigation System II | Remex Medical Corporation | Medical & surgical | Deployed | 2024-05-01 | High | 510(k) ↗ |
| DuraPro Oscillating System | Globus Medical, Inc. | Medical & surgical | Deployed | 2024-04-29 | High | 510(k) ↗ |
| Virage Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | Medical & surgical | Deployed | 2024-04-05 | High | 510(k) ↗ |
| Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine | Medical & surgical | Deployed | 2024-03-29 | High | 510(k) ↗ |
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical | Medical & surgical | Deployed | 2024-03-14 | High | 510(k) ↗ |
| Ortho Guidance Precision Knee | Stryker | Medical & surgical | Deployed | 2024-03-14 | High | 510(k) ↗ |
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2024-03-14 | High | 510(k) ↗ |
| Ortho Guidance Precision Knee | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2024-03-14 | High | 510(k) ↗ |
| Kalitec Navigated System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | Medical & surgical | Deployed | 2023-12-13 | High | 510(k) ↗ |
| RIWOtrack Navigation System | Fiagon GmbH | Medical & surgical | Deployed | 2023-11-20 | High | 510(k) ↗ |
| Vital Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | Medical & surgical | Deployed | 2023-11-16 | High | 510(k) ↗ |
| CoreLink Robotic Navigation | Corelink, LLC | Medical & surgical | Deployed | 2023-10-27 | High | 510(k) ↗ |
| Invictus Robotic Navigation | Alphatec Spine, Inc. | Medical & surgical | Deployed | 2023-10-06 | High | 510(k) ↗ |
| Fusion Robotic Navigation System | Alphatec Spine, Inc. | Medical & surgical | Deployed | 2023-09-08 | High | 510(k) ↗ |
| ASTRA & AVANT Navigation System and ASTRA-OCT Navigation System | Spinecraft, LLC | Medical & surgical | Deployed | 2023-07-20 | High | 510(k) ↗ |
| Robotic Graft Delivery | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2023-07-18 | High | 510(k) ↗ |
| POINT Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | Medical & surgical | Deployed | 2023-07-17 | High | 510(k) ↗ |
| Zavation Navigation System | Zavation Medical Products, LLC | Medical & surgical | Deployed | 2023-07-12 | High | 510(k) ↗ |
| VADER Pedicle System Navigated | Icotec AG | Medical & surgical | Deployed | 2023-06-27 | High | 510(k) ↗ |
| CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2023-05-26 | High | 510(k) ↗ |
| Paradigm System | Proprio, Inc. | Medical & surgical | Deployed | 2023-04-21 | High | 510(k) ↗ |
| Anatase Spine Surgery Navigation System | Remex Medical Corporation | Medical & surgical | Deployed | 2023-04-21 | High | 510(k) ↗ |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | Intuitive Surgical | Medical & surgical | Deployed | 2023-03-16 | High | 510(k) ↗ |
| EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2023-03-16 | High | 510(k) ↗ |
| PathKeeper System | Pathkeeper Surgical , Ltd. | Medical & surgical | Deployed | 2023-03-08 | High | 510(k) ↗ |
| Ortho Guidance Precision Knee , Ortho Guidance Express Knee , Ortho Guidance Versatile Hip , Ortho Q Guidance System | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2023-02-13 | High | 510(k) ↗ |
| Blueprint Mixed Reality system | Tornier S.A.S. | Medical & surgical | Deployed | 2023-01-20 | High | 510(k) ↗ |
| TELIGEN System Navigation Ready Indications | Medos International SARL | Medical & surgical | Deployed | 2023-01-19 | High | 510(k) ↗ |
| Curiteva Navigation System | Curiteva, Inc. | Medical & surgical | Deployed | 2023-01-06 | High | 510(k) ↗ |
| da Vinci X Surgical System , da Vinci Xi Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2022-11-22 | High | 510(k) ↗ |
| da Vinci X Surgical System , da Vinci Xi Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2022-11-22 | High | 510(k) ↗ |
| Yomi Robotic System | Neocis, Inc. | Medical & surgical | Deployed | 2022-11-04 | High | 510(k) ↗ |
| Remi Robotic Navigation System | Fusion Robotics, LLC | Medical & surgical | Deployed | 2022-10-28 | High | 510(k) ↗ |
| Cirq Arm System | Brainlab AG | Medical & surgical | Deployed | 2022-10-27 | High | 510(k) ↗ |
| da Vinci Firefly Imaging System | Intuitive Surgical | Medical & surgical | Deployed | 2022-10-20 | High | 510(k) ↗ |
| Rosa Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | Medical & surgical | Deployed | 2022-10-04 | High | 510(k) ↗ |
| Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth Edition | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2022-09-29 | High | 510(k) ↗ |
| XACT Robotic System, ACE Model | Xact Robotics, Ltd. | Medical & surgical | Deployed | 2022-09-23 | High | 510(k) ↗ |
| Spine & Trauma Navigation, Spine Navigation, Navigation Spine & Trauma, Alignment System Spine, Alignment Spine, Cirq Arm System | Brainlab AG | Medical & surgical | Deployed | 2022-08-30 | High | 510(k) ↗ |
| POINT Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc. | Medical & surgical | Deployed | 2022-08-09 | High | 510(k) ↗ |
| Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corporation | Medical & surgical | Deployed | 2022-07-14 | High | 510(k) ↗ |
| SkyWalker Total Knee System | Microport Navibot International, LLC | Medical & surgical | Deployed | 2022-07-07 | High | 510(k) ↗ |
| Yomi Robotic System with YomiPlan Go | Neocis, Inc. | Medical & surgical | Deployed | 2022-06-14 | High | 510(k) ↗ |
| Spine Guidance , Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2022-05-27 | High | 510(k) ↗ |
| Anteralign Spinal System with Titan NanoLOCK Surface Technology Navigated | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2022-05-25 | High | 510(k) ↗ |
| 7D Surgical System - Percutaneous Application | 7D Surgical, Inc. | Medical & surgical | Deployed | 2022-05-20 | High | 510(k) ↗ |
| XACT ACE Robotic System | Xact Robotics, Ltd. | Medical & surgical | Deployed | 2022-05-13 | High | 510(k) ↗ |
| Universal Pilot Guidance System | Ctl Medical Corporation | Medical & surgical | Deployed | 2022-05-12 | High | 510(k) ↗ |
| Camber Spine Navigation System | Camber Spine Technologies | Medical & surgical | Deployed | 2022-04-29 | High | 510(k) ↗ |
| Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Selection, Fluoro 3D, Registration Fluoro 3D, Registration Paired Point, Registration Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning | Brainlab AG | Medical & surgical | Deployed | 2022-04-13 | High | 510(k) ↗ |
| NEXXT SPINE NAVIGATION System | Nexxt Spine, LLC | Medical & surgical | Deployed | 2022-03-31 | High | 510(k) ↗ |
| Catalyft PL Expandable Interbody System Navigated , Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated , and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2022-02-09 | High | 510(k) ↗ |
| iASSIST Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | Medical & surgical | Deployed | 2022-01-14 | High | 510(k) ↗ |
| Vital Navigation System | Zimvie (Zimmer Biomet Spine, Inc.) | Medical & surgical | Deployed | 2022-01-07 | High | 510(k) ↗ |
| da Vinci SP Firefly Imaging System | Intuitive Surgical | Medical & surgical | Deployed | 2021-11-23 | High | 510(k) ↗ |
| da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2021-11-23 | High | 510(k) ↗ |
| Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | Medical & surgical | Deployed | 2021-11-12 | High | 510(k) ↗ |
| Dark Star Navigation System | Republic Spine, LLC | Medical & surgical | Deployed | 2021-09-27 | High | 510(k) ↗ |
| Virage Navigation System | Zimmer Biomet Spine, Inc. | Medical & surgical | Deployed | 2021-08-27 | High | 510(k) ↗ |
| GX Navigation System | Life Spine, Inc. | Medical & surgical | Deployed | 2021-08-19 | High | 510(k) ↗ |
| Senhance Surgical System | Asensus Surgical, Inc. | Medical & surgical | Deployed | 2021-07-27 | High | 510(k) ↗ |
| ARVIS Surgical Navigation System | Insight Medical Systems, Inc. | Medical & surgical | Deployed | 2021-07-14 | High | 510(k) ↗ |
| CD Horizon Spinal System | Medtronic | Medical & surgical | Deployed | 2021-06-23 | High | 510(k) ↗ |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical | Medical & surgical | Deployed | 2021-04-26 | High | 510(k) ↗ |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2021-04-26 | High | 510(k) ↗ |
| ROSA Partial Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | Medical & surgical | Deployed | 2021-04-19 | High | 510(k) ↗ |
| OMNIVision system | Corin, Ltd. | Medical & surgical | Deployed | 2021-04-12 | High | 510(k) ↗ |
| 7D Surgical System - Drill Guide | 7D Surgical, Inc. | Medical & surgical | Deployed | 2021-03-23 | High | 510(k) ↗ |
| AQUABEAM Robotic System | Procept BioRobotics | Medical & surgical | Deployed | 2021-03-11 | High | 510(k) ↗ |
| AQUABEAM Robotic System | Procept Biorobotics, Corporation | Medical & surgical | Deployed | 2021-03-11 | High | 510(k) ↗ |
| Practical Navigation Surgical Guidance System | Practical Navigation, LLC | Medical & surgical | Deployed | 2021-02-24 | High | 510(k) ↗ |
| VELYS Robotic-Assisted Solution | Depuy Ireland UC | Medical & surgical | Deployed | 2021-01-14 | High | 510(k) ↗ |
| ChoiceSpine Navigation System | Choice Spine, LLC | Medical & surgical | Deployed | 2021-01-04 | High | 510(k) ↗ |
| CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab AG | Medical & surgical | Deployed | 2020-12-23 | High | 510(k) ↗ |
| da Vinci Xi Surgical System , da Vinci X Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2020-12-10 | High | 510(k) ↗ |
| da Vinci Xi Surgical System , da Vinci X Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2020-12-10 | High | 510(k) ↗ |
| Navbit Sprint System- Supine Registration, Navbit Sprint - Lateral Registration | Navbit Pty, Ltd. | Medical & surgical | Deployed | 2020-12-10 | High | 510(k) ↗ |
| da Vinci SP Surgical System, Model SP1098, EndoWrist SP , and | Intuitive Surgical | Medical & surgical | Deployed | 2020-11-12 | High | 510(k) ↗ |
| da Vinci SP Surgical System, Model SP1098, EndoWrist SP , and | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2020-11-12 | High | 510(k) ↗ |
| iFuse Implant System - iFuse Navigation | SI-BONE, Inc. | Medical & surgical | Deployed | 2020-11-09 | High | 510(k) ↗ |
| da Vinci SP Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2020-09-28 | High | 510(k) ↗ |
| da Vinci SP Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2020-09-28 | High | 510(k) ↗ |
| Navigation Module of the Momentum System | Ulrich Medical USA, Inc. | Medical & surgical | Deployed | 2020-09-10 | High | 510(k) ↗ |
| ExactechGPS System | Blue Ortho | Medical & surgical | Deployed | 2020-09-02 | High | 510(k) ↗ |
| Joimax Intracs System | Joimax GmbH | Medical & surgical | Deployed | 2020-07-30 | High | 510(k) ↗ |
| OMNIBotics Knee System | Corin, Ltd. | Medical & surgical | Deployed | 2020-06-27 | High | 510(k) ↗ |
| Naviswiss Hip Navigation System | Naviswiss AG | Medical & surgical | Deployed | 2020-06-10 | High | 510(k) ↗ |
| Tek RMD TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07 | Matia Robotics (Us), Inc. | Medical & surgical | Deployed | 2020-05-29 | High | 510(k) ↗ |
| da Vinci X and Xi Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2020-03-31 | High | 510(k) ↗ |
| da Vinci X and Xi Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2020-03-31 | High | 510(k) ↗ |
| Vital Navigation System | Zimmer Biomet Spine, Inc. | Medical & surgical | Deployed | 2019-12-02 | High | 510(k) ↗ |
| Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | Medical & surgical | Deployed | 2019-10-24 | High | 510(k) ↗ |
| XACT Robotic System | Xact Robotics, Ltd. | Medical & surgical | Deployed | 2019-10-03 | High | 510(k) ↗ |
| Intellijoint Navigation System | Intellijoint Surgical, Inc. | Medical & surgical | Deployed | 2019-10-01 | High | 510(k) ↗ |
| INTAI Surgery Navigation System | Intai Technology Corporation | Medical & surgical | Deployed | 2019-09-20 | High | 510(k) ↗ |
| GALILEO Spine Alignment Monitoring System | MiRus, LLC | Medical & surgical | Deployed | 2019-06-17 | High | 510(k) ↗ |
| SPINEART Navigation System | Spineart SA | Medical & surgical | Deployed | 2019-06-10 | High | 510(k) ↗ |
| Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | Medical & surgical | Deployed | 2019-05-22 | High | 510(k) ↗ |
| Stryker Navigation System with SpineMap Go Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | Stryker Corporation | Medical & surgical | Deployed | 2019-02-14 | High | 510(k) ↗ |
| AQrate Robotic Assistance System | Globus Medical, Inc. | Medical & surgical | Deployed | 2019-01-29 | High | 510(k) ↗ |
| Senhance Ultrasonic System | Transenterix, Inc. | Medical & surgical | Deployed | 2019-01-11 | High | 510(k) ↗ |
| Choice Spine Navigation System | Choicespine, LP | Medical & surgical | Deployed | 2019-01-08 | High | 510(k) ↗ |
| CD HORIZON Spinal System for use with MAZOR X Stealth Edition | Medtronic Sofamor Danek USA, Inc. | Medical & surgical | Deployed | 2018-11-02 | High | 510(k) ↗ |
| Mazor X System | Mazor Robotics , Ltd. | Medical & surgical | Deployed | 2018-11-02 | High | 510(k) ↗ |
| NavLock Trackers, Robotic Reference Frame | Medtronic Navigation, Inc. | Medical & surgical | Deployed | 2018-11-02 | High | 510(k) ↗ |
| Senhance Surgical System | Transenterix, Inc. | Medical & surgical | Deployed | 2018-10-09 | High | 510(k) ↗ |
| NuVasive Pulse System | Nu Vasive, Incorporated | Medical & surgical | Deployed | 2018-06-29 | High | 510(k) ↗ |
| da Vinci SP Surgical System, EndoWrist SP , and | Intuitive Surgical | Medical & surgical | Deployed | 2018-05-31 | High | 510(k) ↗ |
| da Vinci SP Surgical System, EndoWrist SP , and | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2018-05-31 | High | 510(k) ↗ |
| TransEnterix Senhance Surgical System | Transenterix, Inc. | Medical & surgical | Deployed | 2018-05-25 | High | 510(k) ↗ |
| SeaSpine Navigation System | SeaSpine Orthopedics Corporation | Medical & surgical | Deployed | 2018-05-11 | High | 510(k) ↗ |
| 7D Surgical System | 7D Surgical, Inc. | Medical & surgical | Deployed | 2018-05-02 | High | 510(k) ↗ |
| Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2018-04-24 | High | 510(k) ↗ |
| NAVIO Surgical System | Blue Belt Technologies, Inc. | Medical & surgical | Deployed | 2018-04-06 | High | 510(k) ↗ |
| da Vinci Xi Surgical System | Intuitive Surgical | Medical & surgical | Deployed | 2018-01-31 | High | 510(k) ↗ |
| Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | Medical & surgical | Deployed | 2018-01-18 | High | 510(k) ↗ |
| Intellijoint HIP System , Intellijoint HIP System , Intellijoint HIP Tray | Intellijoint Surgical, Inc. | Medical & surgical | Deployed | 2017-11-16 | High | 510(k) ↗ |
| Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. | Medical & surgical | Deployed | 2017-10-30 | High | 510(k) ↗ |
| Stryker Spine Navigation System with SpineMap 3D application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap | Stryker Corporation | Medical & surgical | Deployed | 2017-10-18 | High | 510(k) ↗ |
| Senhance Surgical Robotic System | Transenterix, Inc. | Medical & surgical | Deployed | 2017-10-13 | High | 510(k) ↗ |
| OMNIBotics Knee System | Omnllife Science, Inc. | Medical & surgical | Deployed | 2017-09-01 | High | 510(k) ↗ |
| Medrobotics Flex Robotic System | Medrobotics Corporation | Medical & surgical | Deployed | 2017-08-03 | High | 510(k) ↗ |
| da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2017-07-28 | High | 510(k) ↗ |
| EndoWrist Stapler 45 System and Stapler 45 Reloads | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2017-05-31 | High | 510(k) ↗ |
| da Vinci X Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2017-05-26 | High | 510(k) ↗ |
| Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | Medical & surgical | Deployed | 2017-05-04 | High | 510(k) ↗ |
| SURESHOT Distal Targeting System V4.0 Trauma Interface | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2017-05-03 | High | 510(k) ↗ |
| Smith & Nephew SURESHOT Distal Targeting System V4.0 | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2017-04-28 | High | 510(k) ↗ |
| Navigated System | Orthofix US, LLC | Medical & surgical | Deployed | 2017-03-13 | High | 510(k) ↗ |
| TSolution One Surgical System Model 210 | THINK Surgical, Inc. | Medical & surgical | Deployed | 2017-03-06 | High | 510(k) ↗ |
| KneeAlign 2 System | Orthalign, Inc. | Medical & surgical | Deployed | 2017-03-02 | High | 510(k) ↗ |
| Intellijoint HIP Generation 2A System | Intellijoint Surgical, Inc. | Medical & surgical | Deployed | 2017-03-02 | High | 510(k) ↗ |
| Stryker OrthoMap Versatile Hip System | Stryker Corporation | Medical & surgical | Deployed | 2017-02-23 | High | 510(k) ↗ |
| Envision 3D: Image Guidance System | 7D Surgical, Inc. | Medical & surgical | Deployed | 2016-12-29 | High | 510(k) ↗ |
| Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | Medical & surgical | Deployed | 2016-10-12 | High | 510(k) ↗ |
| Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | Medical & surgical | Deployed | 2016-09-20 | High | 510(k) ↗ |
| TSolution One Cup1 Surgical System | THINK Surgical, Inc. | Medical & surgical | Deployed | 2016-09-14 | High | 510(k) ↗ |
| Styrker OrthoMap Express Knee System | Stryker Corporate | Medical & surgical | Deployed | 2016-07-07 | High | 510(k) ↗ |
| Stealth-Midas System | Medtronic Powered Surgical Solutions | Medical & surgical | Deployed | 2016-05-26 | High | 510(k) ↗ |
| Auris Robotic Endoscopy System | Auris Surgical Robotics, Inc. | Medical & surgical | Deployed | 2016-05-26 | High | 510(k) ↗ |
| da Vinci Surgical System, Model IS4000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2016-03-30 | High | 510(k) ↗ |
| TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | Medical & surgical | Deployed | 2016-02-16 | High | 510(k) ↗ |
| Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | Medical & surgical | Deployed | 2016-02-01 | High | 510(k) ↗ |
| da Vinci Xi Surgical System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2016-01-15 | High | 510(k) ↗ |
| Intellijoint HIP System | Intellijoint Surgical, Inc. | Medical & surgical | Deployed | 2015-12-28 | High | 510(k) ↗ |
| Hansen Medical Magellan Robotic Catheter 6Fr and Components | Hansen Medical, Inc. | Medical & surgical | Deployed | 2015-08-18 | High | 510(k) ↗ |
| Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | Medical & surgical | Deployed | 2015-07-01 | High | 510(k) ↗ |
| Tek RMD | Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S | Medical & surgical | Deployed | 2015-06-11 | High | 510(k) ↗ |
| MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | Mako Surgical Corporation | Medical & surgical | Deployed | 2014-11-13 | High | 510(k) ↗ |
| FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | Omniguide, Inc. | Medical & surgical | Deployed | 2014-09-25 | High | 510(k) ↗ |
| DA VINVI SURGICAL SYSTEM | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2014-09-17 | High | 510(k) ↗ |
| IASSIST KNEE SYSTEM | Zimmer Cas | Medical & surgical | Deployed | 2014-09-11 | High | 510(k) ↗ |
| Renaissance X System | Mazor Robotics , Ltd. | Medical & surgical | Deployed | 2014-09-10 | High | 510(k) ↗ |
| da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2014-08-12 | High | 510(k) ↗ |
| Magellan Robotic System | Hansen Medical, Inc. | Medical & surgical | Deployed | 2014-08-07 | High | 510(k) ↗ |
| SENSEI X ROBOTIC CATHETER SYSTEM | Hanson Medical, Inc. | Medical & surgical | Deployed | 2014-08-05 | High | 510(k) ↗ |
| OrthAlign Plus System | Orthalign, Inc. | Medical & surgical | Deployed | 2014-06-10 | High | 510(k) ↗ |
| DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2014-04-17 | High | 510(k) ↗ |
| DA VINCI SURGICAL SYSTEM, ENDOWRIST AND | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2014-03-28 | High | 510(k) ↗ |
| MAGELLAN ROBOTIC CATHETER 6FR , MAGELLAN ROBOTIC CATHETER 6FR | Hansen Medical, Inc. | Medical & surgical | Deployed | 2014-02-07 | High | 510(k) ↗ |
| ORTHOALIGN PLUS SYSTEM | Orthalign, Inc. | Medical & surgical | Deployed | 2013-11-08 | High | 510(k) ↗ |
| MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | Medical & surgical | Deployed | 2013-09-27 | High | 510(k) ↗ |
| SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2013-08-04 | High | 510(k) ↗ |
| PASSPORT ROBOTIC REDUCER CAP | Stryker Endoscopy | Medical & surgical | Deployed | 2013-08-01 | High | 510(k) ↗ |
| TRANSCRANIAL DOPPLER WITH ROBOTIC HEADBAND | Shenzhen Delicate Electronics Co., Ltd. | Medical & surgical | Deployed | 2013-02-15 | High | 510(k) ↗ |
| CONNECT FOR DA VINCI SURGICAL SYSTEM | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2013-02-14 | High | 510(k) ↗ |
| SCULPTOR ROBOTIC GUIDANCE ARM | Stanmore Implants Worldwide , Ltd. | Medical & surgical | Deployed | 2013-01-11 | High | 510(k) ↗ |
| NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | Medical & surgical | Deployed | 2012-12-07 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2012-12-03 | High | 510(k) ↗ |
| SMARTTOOLS KNEE SYSTEM | Zimmer | Medical & surgical | Deployed | 2012-11-30 | High | 510(k) ↗ |
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | Medical & surgical | Deployed | 2012-10-26 | High | 510(k) ↗ |
| ENDOWRIST STAPLER SYSTEM | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2012-10-17 | High | 510(k) ↗ |
| MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | Mako Surgical Corporation | Medical & surgical | Deployed | 2012-06-06 | High | 510(k) ↗ |
| RESTORIS PARTIAL KNEE APPLICATION , RIO STANDARD SYSTEM | Mako Surgical Corporation | Medical & surgical | Deployed | 2012-03-01 | High | 510(k) ↗ |
| BENDINI SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | Medical & surgical | Deployed | 2011-12-05 | High | 510(k) ↗ |
| ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM | Smith & Nephew Inc., Endoscopy Div. | Medical & surgical | Deployed | 2011-11-14 | High | 510(k) ↗ |
| SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2011-04-14 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2011-04-08 | High | 510(k) ↗ |
| NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | Zimmer Cas | Medical & surgical | Deployed | 2011-03-24 | High | 510(k) ↗ |
| SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2. | Smith & Newphew, Inc. | Medical & surgical | Deployed | 2010-11-04 | High | 510(k) ↗ |
| SENSEI X ROBOTIC CATHETER SYSTEM | Hansen Medical, Inc. | Medical & surgical | Deployed | 2010-10-22 | High | 510(k) ↗ |
| KNEEALIGN SYSTEM WITH REFERENCE SENSOR | Orthalign, Inc. | Medical & surgical | Deployed | 2010-03-22 | High | 510(k) ↗ |
| MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | Mako Surgical Corporation | Medical & surgical | Deployed | 2010-02-24 | High | 510(k) ↗ |
| SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2010-02-23 | High | 510(k) ↗ |
| 5 MM HARMONIC ACE | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2010-01-21 | High | 510(k) ↗ |
| TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK | Praxim Medivision, SA | Medical & surgical | Deployed | 2010-01-21 | High | 510(k) ↗ |
| ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | Mako Surgical Corporation | Medical & surgical | Deployed | 2009-09-28 | High | 510(k) ↗ |
| KNEEALIGN SYSTEM | Orthalign, Inc. | Medical & surgical | Deployed | 2009-09-25 | High | 510(k) ↗ |
| SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2009-09-11 | High | 510(k) ↗ |
| SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Hansen Medical, Inc. | Medical & surgical | Deployed | 2009-09-10 | High | 510(k) ↗ |
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | Mako Surgical Corporation | Medical & surgical | Deployed | 2009-06-19 | High | 510(k) ↗ |
| SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V | Smith & Nephew, Inc. | Medical & surgical | Deployed | 2009-05-27 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2009-02-18 | High | 510(k) ↗ |
| IMNS MEDACTA NAVIGATION SYSTEM | Medacta International S.A. | Medical & surgical | Deployed | 2009-01-15 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2008-12-19 | High | 510(k) ↗ |
| INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 | Intouch Technologies | Medical & surgical | Deployed | 2008-04-11 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC AND CONTROL SYSTEM AND ENDOWRIST STABILIZER | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2008-03-19 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC AND ENDOWRIST CARDIAC GRASPER | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2008-02-14 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC AND ENDOWRIST INTRODUCER | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2008-02-07 | High | 510(k) ↗ |
| MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | Medical & surgical | Deployed | 2007-08-22 | High | 510(k) ↗ |
| DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2006-12-01 | High | 510(k) ↗ |
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM | Accuray Incorporated | Medical & surgical | Deployed | 2006-09-28 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2005-04-29 | High | 510(k) ↗ |
| MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2005-03-03 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC , MODELS IS1200 & IS1000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2004-12-15 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM AND ENDOSCOPIC | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2004-07-07 | High | 510(k) ↗ |
| BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM | Computer Motion, Inc. | Medical & surgical | Deployed | 2003-06-24 | High | 510(k) ↗ |
| INTUITIVE SURGICAL ENDOSCOPIC CONTROL SYSTEM & ENDOSCOPIC , MODEL DA VINCI ISI 1000/1200 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2002-11-12 | High | 510(k) ↗ |
| ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND | Computer Motion, Inc. | Medical & surgical | Deployed | 2002-09-24 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2002-06-26 | High | 510(k) ↗ |
| ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM | Computer Motion, Inc. | Medical & surgical | Deployed | 2002-03-28 | High | 510(k) ↗ |
| SOCRATES ROBOTIC TELEMONITORING SYSTEM | Computer Motion, Inc. | Medical & surgical | Deployed | 2001-10-05 | High | 510(k) ↗ |
| ZEUS ROBOTIC SURGICAL SYSTEM | Computer Motion, Inc. | Medical & surgical | Deployed | 2001-10-05 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2001-05-30 | High | 510(k) ↗ |
| INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2001-03-02 | High | 510(k) ↗ |
| INTUITIVE SURGICAL ENDOSCOPIC , INTUITIVE SURGICAL ENDOSCOPIC CONTROL SYSTEM | Intuitive Surgical, Inc. | Medical & surgical | Deployed | 2000-07-11 | High | 510(k) ↗ |
| RTD ARM ASSISTIVE ROBOTIC DEVICE | Rehabilitation Technologies Division | Medical & surgical | Deployed | 1999-12-17 | High | 510(k) ↗ |
| SELF PROPELLED ROBOTIC WHEEL | Datatran, Inc. | Medical & surgical | Deployed | 1996-09-03 | High | 510(k) ↗ |
| MARK 5 ROBOTIC PIPETTOR | Diagnostic Products Corp. | Medical & surgical | Deployed | 1991-06-06 | High | 510(k) ↗ |
| FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Medical & surgical | Deployed | 1990-12-31 | High | 510(k) ↗ |
| ROBOTIC SAMPLE PROCESSOR | Tecan U.S., Ltd. | Medical & surgical | Deployed | 1989-08-15 | High | 510(k) ↗ |
| DELTA ROBOTIC PIPETTOR | Diagnostic Products Corp. | Medical & surgical | Deployed | 1989-06-21 | High | 510(k) ↗ |
| TECAN ROBOTIC SAMPLE PROCESSOR #500 | Tecan U.S., Ltd. | Medical & surgical | Deployed | 1986-02-10 | High | 510(k) ↗ |
By status
Counted from the ledger.
Announced outnumbers Deployed and Pilot combined, 6 to 3. That ratio is the whole argument of this page.
What Deployed asserts
Cleared for market by the cited filing, and nothing more. It does not assert an installed base, units shipped or revenue — those are not in a clearance record, so they are not claimed here. A system appears once a regulator has cleared it; an announcement is not enough.