FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
17881–17904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6,...
K202048 · LXB
Cochlear Americas
Ear, Nose, Throat · 214d
Cleared Feb 23, 2021
Molekule Air Mini, Molekule Air Mini +
K202339 · FRA
Molekule, Inc.
General Hospital · 190d
Cleared Feb 23, 2021
Monaco Rtp System
K202789 · MUJ
Elekta Solutions AB
Radiology · 154d
Cleared Feb 23, 2021
StitchKit COMBO
K202950 · GAM
Origami Surgical
General & Plastic Surgery · 146d
Cleared Feb 23, 2021
Lumify Diagnostic Ultrasound System
K203406 · IYN
Philips Ultrasound, Inc.
Radiology · 96d
Cleared Feb 23, 2021
Nissha Medical Technologies Neutral Electrodes
K203494 · GEI
Nissha Medical Technologies, Ltd.
General & Plastic Surgery · 88d
Cleared Feb 23, 2021
PreXion3D Explorer PRO
K203784 · OAS
Prexion Corporation
Radiology · 57d
Cleared Feb 23, 2021
Global Med Systems Milesman Compact Laser
K203804 · GEX
Global Med Systems SL
General & Plastic Surgery · 57d
Cleared CT Feb 23, 2021
ClotTriever Thrombectomy System
K210190 · QEW
Irani Medical, Inc.
Cardiovascular · 29d
Cleared Feb 23, 2021
PowerDot PD-01MT2 Muscle Stimulator
K210269 · IPF
Smartmissimo Technologies Pte, Ltd.
Physical Medicine · 22d
Cleared Feb 22, 2021
Foot and Ankle System
K200062 · HRS
Leith Medical, LLC
Orthopedic · 406d
Cleared Feb 22, 2021
COBRA-OS Kit
K201652 · MJN
Front Line Medical Technologies, Inc.
Cardiovascular · 249d
Cleared Feb 22, 2021
Phyziofit Medical Surgical Mask
K201868 · FXX
Wellpower Sporting Goods Co., Ltd.
General Hospital · 230d
Cleared Feb 22, 2021
Parcus Titanium Interference Screws
K202662 · MBI
Parcus Medical, LLC
Orthopedic · 161d
Cleared Feb 22, 2021
MectaLock Extension
K203493 · MAI
Medacta International S.A.
Orthopedic · 87d
Cleared Feb 22, 2021
Surn5 Electrosurgical Argon Beam Generator and Accessories
K203522 · GEI
Surnic Corporation
General & Plastic Surgery · 83d
Cleared Feb 22, 2021
Air Compression Therapy Device, model HW6007
K210240 · IRP
Konliking Tech & Dev. Limited
Physical Medicine · 24d
Cleared Feb 21, 2021
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
K202112 · PZL
Storz Medical AG
General & Plastic Surgery · 206d
Cleared Feb 19, 2021
pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based,...
K200527 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 354d
Cleared Feb 19, 2021
MyPAO Planning Report
K200589 · LLZ
Medacta International S.A.
Radiology · 350d
Cleared Feb 19, 2021
iMask Disposable Surgical Face Mask
K201182 · FXX
Pac-Dent, Inc.
General Hospital · 294d
Cleared Feb 19, 2021
Ultrasonic Osteotomy Surgical System
K201274 · JDX
Smtp Technology Co., Ltd.
Orthopedic · 283d
Cleared Feb 19, 2021
Artemis Proximal Femoral Nail System
K201379 · HSB
Glw, Inc.
Orthopedic · 269d
Cleared Feb 19, 2021
Disposable Intraoperative Probe (DIOP8)
K201425 · ITX
Huntleigh Healthcare Limited
Radiology · 266d