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
20017–20040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2020
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · DIO
Medtest DX
Toxicology · 267d
Cleared Mar 12, 2020
SpaceStation MRI
K191910 · MRZ
B. Braun Melsugen AG
General Hospital · 239d
Cleared Mar 12, 2020
NEOLab Clear Aligners
K192338 · NXC
New England Ortho Lab, Inc.
Dental · 197d
Cleared Mar 12, 2020
SonoVision Ultrasound Imaging System
K192388 · IYN
Tissue Differentiation Intelligence, LLC
Radiology · 191d
Cleared Mar 12, 2020
elysion-pro
K193367 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 99d
Cleared Mar 12, 2020
BioNourish Lubricant
K193448 · NUC
Good Clean Love, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 12, 2020
Tritium Sternal Cable Plate System
K193468 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 12, 2020
AMT Suture Delivery System
K193612 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 12, 2020
Health Line CT Midline Catheter
K200263 · FOZ
Health Line International Corporation
General Hospital · 38d
Cleared Mar 12, 2020
Arthrex FiberTak Suture Anchor
K200341 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Mar 11, 2020
AC5 Topical Gel
K190129 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 408d
Cleared Mar 11, 2020
Fixone Biocomposite Anchor
K192484 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 183d
Cleared Mar 11, 2020
Apollo Suture Anchor System
K192810 · MBI
Valeris Medical
Orthopedic · 162d
Cleared Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
K192924 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 147d
Cleared Mar 11, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · PBF
KLS-Martin L.P.
Orthopedic · 139d
Cleared Mar 11, 2020
Vista Dyes
K193447 · LFC
Inter-Med/Vista Dental Products
Dental · 89d
Cleared Mar 11, 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous...
K200328 · OQG
Kyocera Medical Technologies, Inc.
Orthopedic · 30d
Cleared Mar 11, 2020
Quidel Triage® TOX Drug Screen, 94600
K200363 · DKZ
Quidel Cardiovascular, Inc.
Toxicology · 26d
Cleared Mar 10, 2020
JR.MEDIK Latex Surgeon’s Gloves Powder Free
K192328 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 196d
Cleared Mar 10, 2020
Bare: 808
K193446 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Mar 10, 2020
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
K193481 · MRN
International Biomedical
Anesthesiology · 84d
Cleared Mar 10, 2020
FlexPointer 1.5 Single Use, FlexTube 3 Single Use
K200041 · PGW
Fiagon GmbH
Ear, Nose, Throat · 62d
Cleared Mar 10, 2020
Rapid Acoustic Pulse Device
K200331 · GEX
Soliton, Inc.
General & Plastic Surgery · 29d