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
20617–20640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 10, 2020
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K200370 · OZE
Centers For Disease Control and...
Microbiology · 25d
Cleared Mar 09, 2020
LiquiBand Plus
K183570 · MPN
Advanced Medical Solutions Limited
General & Plastic Surgery · 444d
Cleared Mar 09, 2020
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve...
K191624 · MNT
Fisher & Paykel Healthcare Limited
Anesthesiology · 265d
Cleared Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K192574 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815 · PRI
Roche Diagnostics
Microbiology · 160d
Cleared Mar 09, 2020
syngo.CT Lung CAD
K193216 · OEB
Siemens Medi Cal Solutions, Inc.
Radiology · 109d
Cleared Mar 09, 2020
DR 600 with Tomosynthesis
K193262 · IZF
Agfa N.V.
Radiology · 104d
Cleared Mar 09, 2020
Pre-Milled Blank
K193425 · NHA
Arum Dentistry Co., Ltd.
Dental · 90d
Cleared Mar 09, 2020
Elite iQ
K193426 · GEX
Cynosure, LLC
General & Plastic Surgery · 90d
Cleared Mar 09, 2020
MectaLIF Anterior Simple
K200048 · MAX
Medacta International S.A.
Orthopedic · 60d