Agency
FDA
The US medical-device regulator: surgical, hospital, and care robots reach the US market through its 510(k), De Novo, and PMA clearance pathways, and it orders device recalls and warning letters.
US Food and Drug Administration · US federal · United States · 240 linked actions · Official site
FDA appears in the DEPLOY registry through 150 incidents investigated and 90 filings decided, the most recent on 2026-08-19.
Leaderboard
Most clearances
Most recalls & enforcement
Incidents investigated (150)
Recall92
- Intuitive Surgical recalls da Vinci SP1098 instrument
Recall · 2026-06-22
- General Mills recalls 730,000 Pillsbury rolls for possible glass contamination at Walmart bakeries
Recall · 2026-06-19
- FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly
Recall · 2026-06-15
- CMR Surgical recalls Versius Surgical System consoles due to Secure Boot cybersecurity vulnerability
Recall · 2026-06-09
- Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death
Recall · 2026-05-28
Show 87 more recall
- THINK Surgical recalls TMINI tracking arrays due to loosening causing potential misalignment
Recall · 2026-05-08
- Intuitive Surgical recalls da Vinci staplers after death and injuries
Recall · 2026-04-15
- Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)
Recall · 2026-04-02
- da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)
Recall · 2026-03-11
- Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death
Recall · 2026-03-11
- Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines
Recall · 2026-03-11
- FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field
Recall · 2026-02-18
- da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use
Recall · 2026-02-02
- Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)
Recall · 2026-01-28
- Auris Health (J&J) recalls Monarch over unanticipated robotic arm positioning toward patient-left
Recall · 2026-01-21
- Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility
Recall · 2025-12-15
- Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables
Recall · 2025-12-09
- Intuitive recalls da Vinci S/Si Permanent Cautery Hook over frayed or broken pitch cables
Recall · 2025-12-09
- Intuitive Surgical recalls 12 da Vinci 5 systems over UI application crash and loss of monitor display
Recall · 2025-11-17
- da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use
Recall · 2025-11-07
- Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use
Recall · 2025-11-07
- Auris Health (J&J) recalls Monarch bronchoscopes over out-of-range leak-test results
Recall · 2025-10-18
- FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure
Recall · 2025-05-16
- Wandercraft recalls Atalante X self-balancing exoskeleton over a lateral-balance issue that can cause patient falls
Recall · 2025-04-03
- da Vinci 5 console foot-pedal recall over a spring failure that can leave a pedal stuck pressed
Recall · 2025-02-26
- Intuitive recalls da Vinci 8mm ProGrasp Forceps over frayed or broken grip cables
Recall · 2024-12-19
- Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables
Recall · 2024-12-19
- Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables
Recall · 2024-12-19
- Intuitive recalls da Vinci Monopolar Curved Scissors over frayed/broken grip cables causing loss of instrument control
Recall · 2024-12-19
- Intuitive recalls da Vinci 8mm Horizon Small Clip Applier over frayed or broken grip cables
Recall · 2024-12-19
- Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)
Recall · 2024-09-04
- Intuitive Surgical recalls 144 da Vinci 5 systems over surgeon console motor connector failure
Recall · 2024-08-21
- Stryker recalls Mako MICS Handpiece (2024) over a characterization error that can cause off-plan bone cuts
Recall · 2024-08-07
- FDA Class 2 recall of Epione needle guide component due to rust
Recall · 2024-08-05
- Auris Health (J&J) recalls Monarch over a power-cord strain-relief electrical short
Recall · 2024-08-02
- Stryker Mako Total Knee software correction over 'error #3' codes when switching applications
Recall · 2024-05-28
- Abbott recalls Liberta RC DBS System due to stimulation turning off at 50-day intervals
Recall · 2024-05-24
- Össur recalls Rheo Knee prosthetic devices due to safety concern
Recall · 2024-03-25
- Auris Health (J&J) recalls Monarch robotic bronchoscopy platform over software bug that can flip the virtual scope view
Recall · 2023-10-18
- Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement
Recall · 2023-10-06
- Asensus Senhance Class I recall: software malfunction caused uncontrolled arm motion after disengaging teleop
Recall · 2023-09-15
- Asensus recalls Senhance Surgical System (Class I) over uncontrolled robotic-arm motion
Recall · 2023-09-15
- Intuitive recalls da Vinci Tip-Up Fenestrated Grasper over grip breakage that can drop steel fragments into patients
Recall · 2023-06-12
- General Mills recalls Gold Medal All Purpose Flour for potential Salmonella Infantis contamination
Recall · 2023-04-28
- Stryker recalls Mako Restoris MCK tibial baseplate trials over incorrect size laser marking
Recall · 2023-03-10
- da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component
Recall · 2023-02-23
- Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review
Recall · 2022-12-19
- da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments
Recall · 2022-10-07
- Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments
Recall · 2022-09-20
- Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement
Recall · 2022-07-01
- FDA Class I recall of 35,950 SafeStar 55 breathing system filters over possible oxygen blockage
Recall · 2022-05-01
- Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding
Recall · 2022-03-17
- Intuitive recalls da Vinci EndoWrist Vessel Sealer Extend instruments over risk of insufficient vessel seals
Recall · 2022-03-03
- Intuitive recalls da Vinci SynchroSeal instruments over risk of insufficient vessel seals
Recall · 2022-03-03
- Abbott voluntary recall of powdered infant formula from Sturgis Michigan facility
Recall · 2022-02-17
- Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients
Recall · 2021-12-23
- Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory
Recall · 2021-09-22
- Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft
Recall · 2021-08-06
- Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)
Recall · 2020-12-02
- Stryker recalls Mako Integrated Cutting System handpiece over checkpoint-verification flaw that could cause off-plan bone cuts
Recall · 2020-10-23
- Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged
Recall · 2020-10-23
- Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals
Recall · 2020-06-10
- FDA Class 2 recall of ReWalk Personal exoskeleton due to battery fire risk
Recall · 2020-02-28
- ReWalk (now Lifeward) recalls personal exoskeletons after battery waistpacks caught fire while charging
Recall · 2020-02-28
- FDA Class 2 recall of Butterfly iQ Auto Bladder Volume Tool for lacking 510(k) clearance
Recall · 2020-02-24
- Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory
Recall · 2019-09-10
- Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors
Recall · 2019-07-26
- Auris Health (J&J) recalls Monarch Aspirating Biopsy Needle over reports of needle breakage
Recall · 2019-04-19
- Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients
Recall · 2018-08-15
- Intuitive recalls da Vinci X systems over a high rate of ACJ board failure
Recall · 2018-03-07
- ReWalk (now Lifeward) recalls Personal 6.0 exoskeleton after tibia and fibula injury complaints
Recall · 2017-08-14
- Stryker recalls Mako RIO over loss of system power mid-procedure
Recall · 2017-06-07
- Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position
Recall · 2017-05-01
- Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position
Recall · 2017-05-01
- Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios
Recall · 2017-03-31
- Zimmer Biomet recalls ROSA Brain 3.0.0 over the head holder connector locking up when tightened
Recall · 2016-10-11
- Intuitive recalls da Vinci EndoWrist Stapler 45 over increased Stapler Firing Failed complaints
Recall · 2016-07-14
- Zimmer Biomet recalls ROSA Brain 3.0 over insufficient washers allowing telescopic-arm movement
Recall · 2016-05-27
- Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command
Recall · 2016-04-08
- Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode
Recall · 2016-01-20
- FDA Class I recall of Dräger Oxylog emergency transport ventilators over ventilation halt risk
Recall · 2016-01-07
- Intuitive recalls da Vinci 30-degree 8mm Endoscope over risk of patient harm from monopolar energy
Recall · 2015-11-23
- Intuitive recalls da Vinci Fundus Grasper over jaws that can become stuck closed
Recall · 2015-08-08
- Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting
Recall · 2014-11-06
- Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy
Recall · 2014-02-14
- da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns
Recall · 2013-05-08
- Intuitive recalls da Vinci 8mm Maryland Bipolar Forceps over a cautery plug insert that can dislodge
Recall · 2013-05-08
- Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability
Recall · 2013-02-05
- FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links
Recall · 2011-02-11
- FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure
Recall · 2009-08-10
- FDA Class 2 recall of Hocoma Lokomat System due to software sensitivity bug
Recall · 2009-05-27
- Wright Medical voluntarily recalled CONSERVE hip system due to metal particle shedding
Recall · 2004-09-20
Regulatory action35
- FDA grants De Novo authorization to Vitestro Aletta, first standalone robotic blood draw device
Regulatory action · 2026-08-19
- FDA grants 510(k) clearance to Momentis Surgical Anovo system for multiport surgery, first platform supporting all three surgical access approaches
Regulatory action · 2026-07-23
- FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries
Regulatory action · 2026-07-22
- FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures
Regulatory action · 2026-07-22
- FDA grants De Novo marketing authorization to J&J Ottava surgical robot
Regulatory action · 2026-07-22
Show 30 more regulatory action
- FDA clears J&J Ottava surgical robot for US launch following de novo submission
Regulatory action · 2026-07-22
- LEM Surgical receives FDA clearance for Dynamis multi-arm surgical robot
Regulatory action · 2026-07-01
- Medtronic Hugo surgical robot earns FDA clearance for additional indication
Regulatory action · 2026-07-01
- FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures
Regulatory action · 2026-07-01
- ROBODOC Surgical System receives FDA 510(k) marketing clearance
Regulatory action · 2026-06-30
- LEM Surgical receives second FDA 510(k) clearance for next-gen robotic surgical system
Regulatory action · 2026-06-23
- Revolve Surgical receives FDA 510(k) clearance for surgical robot platform
Regulatory action · 2026-06-15
- Happy Ring earns second FDA clearance for at-home sleep testing
Regulatory action · 2026-06-15
- THINK Surgical receives FDA 510(k) clearance for TMINI 1.1
Regulatory action · 2026-06-15
- Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications
Regulatory action · 2026-06-15
- Movano Health secures FDA clearance for EvieMED Ring
Regulatory action · 2026-06-15
- FDA grants 510(k) clearance for Stereotaxis Synchrony system for digital cath lab
Regulatory action · 2026-04-06
- Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments
Regulatory action · 2026-03-31
- Butterfly Network receives FDA clearance for AI ultrasound fetal biometric tool
Regulatory action · 2026-03-30
- Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers
Regulatory action · 2026-03-26
- CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery
Regulatory action · 2026-03-15
- FDA grants Breakthrough Device Designation for NIA Therapeutics memory restoration implant
Regulatory action · 2026-03-01
- Medtronic Hugo robotic surgery system cleared by FDA for urologic procedures
Regulatory action · 2026-02-15
- AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect
Regulatory action · 2026-02-04
- Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures
Regulatory action · 2026-01-26
- Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification
Regulatory action · 2026-01-07
- FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))
Regulatory action · 2025-12-17
- FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures
Regulatory action · 2025-12-03
- FDA clears Intuitive Surgical Ion software upgrade with AI-powered navigation and advanced imaging for lung biopsy
Regulatory action · 2025-10-08
- Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system
Regulatory action · 2025-09-08
- FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance
Regulatory action · 2025-07-14
- FDA clears Quantum Surgical Epione robot for abdominal tumor ablation
Regulatory action · 2025-03-26
- FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities
Regulatory action · 2023-08-30
- FDA 510(k) clearance for POINT Kinguide robotic-assisted spinal surgery system
Regulatory action · 2022-08-23
- FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events
Regulatory action · 2013-07-19
Injury12
- Medtronic Hugo RAS: bipolar grasper broke and dropped a resin insulator fragment into a patient (FDA MAUDE)
Injury · 2026-05-11
- Auris Monarch: patient developed pneumothorax post-procedure requiring chest-tube placement (FDA MAUDE)
Injury · 2026-04-30
- da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)
Injury · 2025-06-18
- Wandercraft Atalante X: patient fall after the assistant released the lift while the therapist stepped away (FDA MAUDE)
Injury · 2025-03-17
- da Vinci endoscope: light left on burned the patient after resting on the thigh (FDA MAUDE)
Injury · 2025-01-21
Show 7 more injury
- Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)
Injury · 2024-06-24
- FDA MAUDE report: Yomi guided dental implant robot serious injury event
Injury · 2024-01-01
- Ekso Bionics EksoNR: knee swelling and a left motor overheating during sit-to-stand (FDA MAUDE)
Injury · 2023-04-14
- Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)
Injury · 2020-11-11
- Ekso Bionics EksoGT: lower-back pain on sit-to-stand in a patient with an incompletely healed femur (FDA MAUDE)
Injury · 2020-10-28
- ReWalk (now Lifeward) Personal 6.0: lateral tibial plateau fracture in a new user (FDA MAUDE)
Injury · 2019-12-18
- REX exoskeleton session resulted in bilateral femur fractures in a spinal cord injury patient with osteoporosis
Injury · 2016-05-02
Malfunction10
- Medtronic Hugo RAS: failure to calibrate with the application program freezing or failing to launch (FDA MAUDE)
Malfunction · 2026-05-21
- Medtronic Hugo RAS: unintended collision with the application program freezing or failing to launch (FDA MAUDE)
Malfunction · 2026-05-14
- Auris Monarch bronchoscope: Navigation EM error at the docking station, scope removed (FDA MAUDE)
Malfunction · 2026-05-08
- CMR Surgical Versius: hand-controller arm went still and console became unrecoverable, forcing open conversion (FDA MAUDE)
Malfunction · 2026-04-07
- Zimmer ROSA Recon: force sensor error and unintended robotic-arm drift during a knee case (FDA MAUDE)
Malfunction · 2026-04-01
Show 5 more malfunction
- Zimmer ROSA Recon: a large amount of sparks with a hole found in the power cord (FDA MAUDE)
Malfunction · 2026-03-09
- Medtronic Hugo RAS: robotic arm froze during undocking, leading to bleeding and open conversion (FDA MAUDE)
Malfunction · 2026-01-16
- Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)
Malfunction · 2025-04-01
- Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)
Malfunction · 2024-08-15
- Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation
Malfunction · 2019-04-22
Fatality1
- Patient death during Epione-assisted liver cancer ablation procedure in France
Fatality · 2023-11-10
Filings decided (90)
Cleared65
- fda 510k
fda 510k · cleared · Decided 2026-06-01
- fda 510k
fda 510k · cleared · Decided 2026-04-01
- fda 510k
fda 510k · cleared · Decided 2026-01-15
- fda 510k
fda 510k · cleared · Decided 2026-01-01
- fda de novo
fda de novo · cleared · Decided 2026-01-01
Show 60 more cleared
- K253661
fda 510k · cleared · Decided 2025-12-22 · THINK Surgical
- fda de novo
fda de novo · cleared · Decided 2025-12-01 · Medtronic
- fda 510k
fda 510k · cleared · Decided 2025-11-10
- K251197
fda 510k · cleared · Decided 2025-09-30
- K250507
fda 510k · cleared · Decided 2025-09-11 · Apple
- K242575
fda 510k · cleared · Decided 2025-05-23 · Brain Navi
- K243326
fda 510k · cleared · Decided 2025-04-23
- fda 510k
fda 510k · cleared · Decided 2025-03-17
- K242121
fda 510k · cleared · Decided 2025-03-14 · Monogram Technologies
- K242967
fda 510k · cleared · Decided 2025-02-25 · Google
- K242967
fda 510k · cleared · Decided 2025-02-01 · Google
- K241822
fda 510k · cleared · Decided 2024-12-01 · Lifeward
- fda 510k
fda 510k · cleared · Decided 2024-11-20
- K242373
fda 510k · cleared · Decided 2024-11-07 · Stryker
- fda de novo
fda de novo · cleared · Decided 2024-10-01 · Distalmotion
- fda de novo
fda de novo · cleared · Decided 2024-10-01 · CMR Surgical
- K240929
fda 510k · cleared · Decided 2024-09-13 · Apple
- K241517
fda 510k · cleared · Decided 2024-08-27 · Stryker
- fda 510k
fda 510k · cleared · Decided 2024-07-23
- K240598
fda 510k · cleared · Decided 2024-06-03 · Moon Surgical
- K241517
fda 510k · cleared · Decided 2024-06-01 · Stryker
- K240598
fda 510k · cleared · Decided 2024-06-01 · Moon Surgical
- K233655
fda 510k · cleared · Decided 2024-05-29 · Abbott
- K233655
fda 510k · cleared · Decided 2024-05-01 · Abbott
- fda 510k
fda 510k · cleared · Decided 2024-04-01
- K232610
fda 510k · cleared · Decided 2024-03-14 · Intuitive Surgical
- K234070
fda 510k · cleared · Decided 2024-03-05 · Dexcom
- K234070
fda 510k · cleared · Decided 2024-03-05 · Dexcom
- DEN230025
fda de novo · cleared · Decided 2024-02-23 · Virtual Incision
- fda 510k
fda 510k · cleared · Decided 2024-01-01 · MicroPort MedBot
- fda 510k
fda 510k · cleared · Decided 2024-01-01 · Stereotaxis
- fda 510k
fda 510k · cleared · Decided 2023-06-01 · Asensus Surgical
- K230292
fda 510k · cleared · Decided 2023-05-02 · Samsung Electronics
- K221774
fda 510k · cleared · Decided 2023-01-12 · Garmin
- K221774
fda 510k · cleared · Decided 2023-01-12 · Garmin
- K232808
fda 510k · cleared · Decided 2023-01-01 · Butterfly Network
- K222750
fda 510k · cleared · Decided 2023-01-01 · Neocis
- K212372
fda 510k · cleared · Decided 2022-04-08 · Fitbit
- K212372
fda 510k · cleared · Decided 2022-04-08 · Fitbit
- fda 510k
fda 510k · cleared · Decided 2022-03-22 · Quantum Surgical
- K201456
fda 510k · cleared · Decided 2021-10-05 · Withings
- K201456
fda 510k · cleared · Decided 2021-10-05 · Withings
- K210989
fda 510k · cleared · Decided 2021-06-01 · Brainlab
- K200948
fda 510k · cleared · Decided 2020-09-11 · Fitbit
- K200948
fda 510k · cleared · Decided 2020-09-11 · Fitbit
- fda 510k
fda 510k · cleared · Decided 2020-01-01 · Smith+Nephew
- fda 510k
fda 510k · cleared · Decided 2019-06-01 · Zimmer Biomet
- K182188
fda 510k · cleared · Decided 2019-02-14 · Intuitive Surgical
- K182964
fda 510k · cleared · Decided 2019-01-24 · Zimmer Biomet
- K251316
fda 510k · cleared · Decided 2018-11-01 · Medtronic
- fda 510k
fda 510k · cleared · Decided 2018-01-01 · Cyberdyne
- fda 510k
fda 510k · cleared · Decided 2018-01-01 · Auris Health
- K171120
fda 510k · cleared · Decided 2017-10-13 · Asensus Surgical
- fda 510k
fda 510k · cleared · Decided 2016-01-01 · Tinavi Medical Technologies
- fda 510k
fda 510k · cleared · Decided 2016-01-01 · Ekso Bionics
- K143690
fda 510k · cleared · Decided 2015-01-01 · Ekso Bionics
- fda 510k
fda 510k · cleared · Decided 2014-06-26 · Lifeward
- K072806
fda 510k · cleared · Decided 2008-01-24 · Stryker
- K990144
fda 510k · cleared · Decided 2000-07-11 · Intuitive Surgical
- fda 510k
fda 510k · cleared · Decided 2000-07-11 · Intuitive Surgical
Recalled13
- Z-1855-2026
fda recall · recalled · Decided 2026-05-01 · Intuitive Surgical
- Z-1232-2026
fda recall · recalled · Decided 2026-02-02 · Intuitive Surgical
- Z-1134-2026
fda recall · recalled · Decided 2026-01-28 · Intuitive Surgical
- Z-1325-2025
fda recall · recalled · Decided 2025-03-12 · Intuitive Surgical
- Z-2720-2024
fda recall · recalled · Decided 2024-09-04 · Intuitive Surgical
Show 8 more recalled
- Z-1910-2024
fda recall · recalled · Decided 2024-05-28 · Stryker
- fda recall
fda recall · recalled · Decided 2023-10-30 · Asensus Surgical
- Z-1262-2023
fda recall · recalled · Decided 2023-03-16 · Intuitive Surgical
- Z-0340-2023
fda recall · recalled · Decided 2022-11-30 · Intuitive Surgical
- fda recall
fda recall · recalled · Decided 2021-10-29 · Zimmer Biomet
- Z-0106-2022
fda recall · recalled · Decided 2021-10-20 · Intuitive Surgical
- Z-0489-2021
fda recall · recalled · Decided 2020-12-02 · Intuitive Surgical
- Z-1442-2013
fda recall · recalled · Decided 2013-05-31 · Intuitive Surgical
Granted4
- K250725
fda 510k · granted · Decided 2025-12-03 · Medtronic
- DEN230078
fda de novo · granted · Decided 2024-10-11 · CMR Surgical
- DEN230041
fda de novo · granted · Decided 2024-02-06 · Samsung Electronics
- DEN180044
fda de novo · granted · Decided 2018-09-11 · Apple
Active4
- 709755
fda warning letter · active · Decided 2025-07-14 · Whoop
- DEN230041
fda de novo · active · Decided 2024-01-01 · Samsung Electronics
- DEN180044
fda de novo · active · Decided 2018-09-11 · Apple
- fda warning letter
fda warning letter · active · Whoop
Pending2
- fda 510k
fda 510k · pending · Decided 2025-12-05
- fda 510k
fda 510k · pending · SS Innovations International
Superseded1
- fda recall
fda recall · superseded · Intuitive Surgical
Closed1
- fda warning letter
fda warning letter · closed · Intuitive Surgical