FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10921–10944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution...
K221198 · NGZ
Thermo Fisher Scientific
Microbiology · 318d
Cleared Mar 10, 2023
Uni Knee Resurfacing System
K221292 · HSX
Overture Resurfacing, Inc.
Orthopedic · 310d
Cleared Mar 10, 2023
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
K221623 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 277d
Cleared Mar 10, 2023
BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device
K222478 · JKA
Becton, Dickinson and Company
General Hospital · 206d
Cleared Mar 10, 2023
Vial Adapter
K222718 · LHI
Hangzhou Qiantang Longyue...
General Hospital · 183d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Mar 10, 2023
uMI Panorama
K223325 · KPS
Shanghai United Imaging Healthcare...
Radiology · 130d
Cleared Mar 10, 2023
ATTUNE® Revision Cones
K230295 · MBH
Depuy Ireland UC
Orthopedic · 36d
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349 · OEM
Quidel Corporation
Microbiology · 29d
Cleared Mar 10, 2023
Arthrex Knotless FiberTak Suture Anchor
K230433 · MBI
Arthrex, Inc.
Orthopedic · 21d
Cleared Mar 09, 2023
DESS Dental Smart Solutions
K221301 · NHA
Terrats Medical SL
Dental · 308d
Cleared Mar 09, 2023
Essenz HLM
K221373 · DTQ
Livanova Deutschland, GmbH
Cardiovascular · 301d
Cleared Mar 09, 2023
AutoPulse NXT Resuscitation System
K221700 · DRM
Zoll Circulation, Inc.
Cardiovascular · 269d
Cleared Mar 09, 2023
AccuContour
K221706 · QKB
Manteia Technologies Co., Ltd.
Radiology · 269d
Cleared Mar 09, 2023
Wesper Lab
K221816 · MNR
Wesper, Inc.
Anesthesiology · 260d
Cleared Mar 09, 2023
DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
K221919 · HRX
Hemodia Sas
Orthopedic · 251d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221930 · QJP
Cerenovus, Inc.
Neurology · 251d
Cleared Mar 09, 2023
CEREGLIDE 71 Intermediate Catheter
K221934 · NRY
Cerenovus, Inc.
Neurology · 251d
Cleared Mar 09, 2023
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN...
K222430 · LON
Biomerieux Sa, Inc.
Microbiology · 210d
Cleared Mar 09, 2023
MultiStage Balloon Dilatation Catheter
K222663 · FGE
Dongguan TT Medical, Inc.
Gastroenterology & Urology · 188d
Cleared Mar 09, 2023
Powered Muscle Stimulator (Model name:MagGraver F200)
K222875 · NGX
Nanjing Vishee Medical Technology...
Physical Medicine · 168d
Cleared Mar 09, 2023
Vassallo GT 018 Hybrid
K223432 · DQX
Filmecc Co., Ltd.
Cardiovascular · 115d
Cleared Mar 09, 2023
Spectral Bone Marrow
K223514 · JAK
Ge Medical Systems, LLC
Radiology · 107d
Cleared Mar 09, 2023
LED Lip Perfector, model: ZC-05
K223642 · ILY
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 93d