FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
4513–4536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
Myolight Microcurrent Handpiece
K243063 · NFO
Raja Trading Company, Inc.
Neurology · 136d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 10, 2025
BTL-398
K241516 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 257d
Cleared Feb 10, 2025
Locking Plates and Screws Systems
K240958 · HRS
Hebei Ruihe Medical Devices Co., Ltd.
Orthopedic · 308d
Cleared Feb 07, 2025
AssureTech Panel Dip Tests
K243996 · NFT
Assure Tech., LLC
Toxicology · 43d
Cleared Feb 07, 2025
HELIOS 785 Pico (1754V2)
K243780 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 60d
Cleared Feb 07, 2025
Electronic Blood Pressure Monitor
K243661 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 72d
Cleared Feb 07, 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · FET
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 107d
Cleared Feb 07, 2025
Identify (4.0)
K242957 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Feb 07, 2025
Any-Com Bulk
K242713 · EBF
Mediclus Co., Ltd.
Dental · 151d
Cleared Feb 07, 2025
Genesys Spine AIS-C II Cervical Interbody Fusion System
K242483 · OVE
Genesys Spine
Orthopedic · 170d
Cleared Feb 07, 2025
BDC Dental Unit
K242404 · EIA
Bdc Dental Corporation , Ltd.
Dental · 178d
Cleared Feb 07, 2025
Symani Surgical System
K242368 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 182d
Cleared Feb 07, 2025
ceramys™ femoral head system
K241483 · LZO
Encore Medical, L.P.
Orthopedic · 259d
Cleared Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
K241453 · QWH
Roche Diagnostics
Chemistry · 261d
Cleared Feb 06, 2025
Resolution Clip (M00522600)
K250066 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 27d
Cleared Feb 06, 2025
Celerity Incubator
K250061 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
K250055 · HRS
Orthonovis, Inc.
Orthopedic · 27d
Cleared Feb 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K250044 · FRC
STERIS Corporation
General Hospital · 27d
Cleared Feb 06, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K244034 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 38d
Cleared Feb 06, 2025
Scorpio Universal Dome Patella
K243817 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Feb 06, 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · IYN
Philips Ultrasound, LLC
Radiology · 58d