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
27145–27168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2017
Operio
K173349 · ORC
Toul Meditech AB
General Hospital · 56d
Cleared Dec 20, 2017
LOGIQ E10
K173555 · IYN
Ge Healthcare
Radiology · 33d
Cleared Dec 20, 2017
Biograph mCT Family of PET/CT Systems
K173578 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Dec 20, 2017
speX Support Catheter
K173662 · DQY
Reflow Medical, Inc.
Cardiovascular · 21d
Cleared Dec 20, 2017
Peel-Away Introducer Set
K173685 · DYB
Cook Incorporated
Cardiovascular · 19d
Cleared Dec 19, 2017
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70...
K170862 · FAJ
Solace Therapeutics, Inc.
Gastroenterology & Urology · 271d
Cleared Dec 19, 2017
Veraview X800
K171012 · OAS
J. Morita USA, Inc.
Radiology · 259d
Cleared Dec 19, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K171552 · OCC
Cepheid
Microbiology · 207d
Cleared Dec 19, 2017
G Surgical OCT Spinal System
K171834 · NKG
G Surgical, LLC
Orthopedic · 182d
Cleared Dec 19, 2017
Reusable Blood Pressure Cuff
K171889 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 176d
Cleared Dec 19, 2017
Advantage Plus Pass-Thru
K172677 · FEB
Medivators, Inc.
General Hospital · 105d
Cleared Dec 19, 2017
Natus VikingQuest
K172743 · IKN
Natus Neurology Incorporated
Neurology · 98d
Cleared Dec 19, 2017
Digital thermometer(with disposable thermometer cover)
K172861 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 90d
Cleared Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
K172944 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Dec 19, 2017
SuperGrow 272, Ultimate 272
K172982 · OAP
Super Grow Lasers
General & Plastic Surgery · 83d
Cleared Dec 19, 2017
Zmachine Synergy
K172986 · OLV
Consolidated Research of Richmond,...
Neurology · 83d
Cleared Dec 19, 2017
Reform® Midline Cortical Screw System
K173130 · NKB
Precision Spine, Inc.
Orthopedic · 81d
Cleared Dec 19, 2017
LumiCoil Platinum Fiducial Marker
K173251 · IYE
Boston Scientific Corporation
Radiology · 70d
Cleared Dec 19, 2017
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
K173307 · JWY
Liofilchem S. R. L.
Microbiology · 62d
Cleared Dec 19, 2017
MAGNETOM Amira
K173600 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 19, 2017
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
K173618 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 27d
Cleared Dec 19, 2017
FS Ergo
K173646 · MUH
Palodex Group OY
Radiology · 22d
Cleared Dec 19, 2017
TBL-ABI System
K173696 · JOM
Ld Technology, LLC
Cardiovascular · 18d
Cleared Dec 18, 2017
PERIO-FLOW nozzle
K171174 · EFB
E.M.S Electro Medical Systems S.A
Dental · 241d