1,024FDA records for robots
What the FDA has cleared
Every clearance, De Novo grant and recall the FDA has published for surgical robots, orthopedic robots and powered exoskeletons. A clearance means the FDA allows a device to be sold; it is not a verdict on how well it works.
- Clearances and grants
- 708
- Recalls
- 316
- Companies
- 201
01Latest decisions
Newest clearances
- 510(k) clearanceCarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics , Ltd. · 9 Oct 2026 · K263154
- 510(k) clearanceSpine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 30 Sept 2026 · K262257
- 510(k) clearanceGeniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 10 Sept 2026 · K253856
- 510(k) clearanceda Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 8 Sept 2026 · K261823da Vinci 5
- 510(k) clearanceTrexo TheoTrexo Robotics, Inc. · 2 Sept 2026 · K254198
- 510(k) clearanceRemex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 20 Aug 2026 · K262506
- De Novo grantAletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)Vitestro · 19 Aug 2026 · DEN250046
- 510(k) clearanceEveWandercraft SAS · 3 Aug 2026 · K260381Medical exoskeletons
- 510(k) clearanceda Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 31 July 2026 · K261824da Vinci 5
- 510(k) clearanceNavbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre · 30 July 2026 · K261410
- 510(k) clearanceSPINEART Navigation Instrument SystemSpineart SA · 29 July 2026 · K261205
- 510(k) clearanceTMINI Miniature Robotic SystemTHINK Surgical, Inc. · 24 July 2026 · K261024
- 510(k) clearanceIon-L Navigated InstrumentsSurGenTec, LLC · 24 July 2026 · K262121
- 510(k) clearanceOp.n Spine Navigation and Robotic GuidanceEcential Robotics · 22 July 2026 · K261113
- De Novo grantOTTAVA Robotic Surgical SystemAuris Health, Inc., part of Johnson & Johnson MedTech · 21 July 2026 · DEN250068Ottava
- 510(k) clearanceHYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept Biorobotics · 9 July 2026 · K260723AquaBeam and HYDROS (Aquablation)
- 510(k) clearanceOTS HipOrtoma AB · 1 July 2026 · K261852
- 510(k) clearanceVERTICALE® Navigation InstrumentsSilony Medical GmbH · 26 June 2026 · K253921
- 510(k) clearanceVELYS Robotic-Assisted SolutionDepuy Ireland UC · 25 June 2026 · K260480
- 510(k) clearanceAQUABEAM Robotic SystemProcept Biorobotics · 23 June 2026 · K253211AquaBeam and HYDROS (Aquablation)
- 510(k) clearanceDynamis Robotic Surgical SystemLEM Surgical AG · 20 June 2026 · K260369
- 510(k) clearanceCORUS Navigation System-GNProvidence Medical Technology, Inc. · 18 June 2026 · K261665
- 510(k) clearanceSIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2 June 2026 · K260571
- 510(k) clearanceNavigated LLIF Impactable TrackerTyber Medical, LLC · 29 May 2026 · K261060
- 510(k) clearanceCROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 26 May 2026 · K254157
- 510(k) clearanceIon-C Navigation InstrumentsSurGenTec, LLC · 22 May 2026 · K260329
- 510(k) clearanceda Vinci Firefly Imaging SystemIntuitive Surgical · 22 May 2026 · K260695da Vinci 5
- 510(k) clearanceROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 21 May 2026 · K260582ROSA
- 510(k) clearanceSenhance Ultrasonic SystemAsensus Surgical · 12 May 2026 · K254192Senhance Surgical System
- 510(k) clearancePytheas Your Guided TrajectoryPytheas Navigation Sas · 11 May 2026 · K252880
- 510(k) clearanceFoundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc. · 16 April 2026 · K260011
- 510(k) clearanceSPINEART Navigation Instrument SystemSpineart SA · 9 April 2026 · K254158
- 510(k) clearanceSYMPHONY Navigation Ready InstrumentsMedos International SARL · 27 March 2026 · K260240
- 510(k) clearanceRobotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)Restore Robotics · 26 March 2026 · K252926
- 510(k) clearanceREAL INTELLIGENCE CORIBlue Belt Technologies, Inc. · 26 March 2026 · K260601
- 510(k) clearanceCUVIS-joint (CJ150)Curexo, Inc. · 25 March 2026 · K252037
- 510(k) clearanceTiLink-L Navigation InstrumentsSurGenTec, LLC · 20 March 2026 · K253604
- 510(k) clearanceEUROPA Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC · 18 March 2026 · K253444
- 510(k) clearanceQ Pedicle InstrumentsK2m, Inc. · 17 March 2026 · K260546
- 510(k) clearanceda Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 11 March 2026 · K253986da Vinci 5
02Recalls
When something went wrong
- RecallConvenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY…Medline Industries, LP · 31 Aug 2026 · R99888da Vinci 5
- RecallIntellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249Intellijoint Surgical, Inc. · 28 Aug 2026 · R99821
- RecallPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE ,…Cardinal Health 200, LLC · 18 Aug 2026 · R99768
- RecallMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AOAmerican Contract Systems Inc · 10 Aug 2026 · R99759
- RecallROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;AVID Medical, Inc. · 10 Aug 2026 · R99808
- Recallhealthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001Healthmark Industries Co., Inc. · 29 July 2026 · R99537
- RecallPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog…Cardinal Health 200, LLC · 29 July 2026 · R99553
- RecallVelys Enabling Tech Robotic-Assist Station REF: 451611001Medos International Sarl · 23 July 2026 · R99467
- RecallMedline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5)…Medline Industries, LP · 10 July 2026 · R99507da Vinci 5
- RecallCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear AcceleratorAccuray Incorporated · 16 June 2026 · R99075CyberKnife
- RecallCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear AcceleratorAccuray Incorporated · 16 June 2026 · R99083CyberKnife
- RecallMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779UMedline Industries, LP · 8 June 2026 · R99301
- RecallTMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement…Think Surgical, Inc. · 8 May 2026 · R99219
- RecallMEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)Medline Industries, LP · 4 May 2026 · R98994
- RecallMedline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G…Medline Industries, LP · 27 April 2026 · R98951
- RecallBrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld…Intuitive Surgical, Inc. · 24 April 2026 · R98569da Vinci 5
- RecallArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker EKico Knee Innovation Company · 23 April 2026 · R98804
- RecallDa Vinci ASSY, PSS, SP1098, Part Number: 380601Intuitive Surgical, Inc. · 22 April 2026 · R98701da Vinci 5
- RecallBrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main…Intuitive Surgical, Inc. · 2 April 2026 · R98564da Vinci 5
- RecallMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit…Medline Industries, LP · 19 March 2026 · R98664da Vinci 5
- RecallIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Intuitive Surgical, Inc. · 11 March 2026 · R98525
- RecallMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.Medline Industries, LP · 27 Feb 2026 · R98598
- RecallMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP…Medline Industries, LP · 27 Feb 2026 · R98601
- RecallConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B…Medline Industries, LP · 27 Feb 2026 · R99062
- RecallDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemOrthalign, Inc · 10 Feb 2026 · R98516
- RecallMICS3 Angled Sagittal Saw Attachment; Part Number: 210490Howmedica Osteonics Corp. · 2 Feb 2026 · R98411
- RecallMedline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5)…Medline Industries, LP · 7 Jan 2026 · R98329
- RecallSee full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model…Medline Industries, LP · 7 Jan 2026 · R98642
- RecallATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments…Alphatec Spine, Inc. · 2 Jan 2026 · R98251
- Recallda Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45Intuitive Surgical, Inc. · 30 Dec 2025 · R98205da Vinci 5
