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
31585–31608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2016
Certus 140 2.45GHz Ablation System
K160936 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 30d
Cleared May 04, 2016
Xenco Medical Pedicle Screw System
K160986 · NKB
Xenco Medical, LLC
Orthopedic · 26d
Cleared May 04, 2016
Soehendra Stent Retriever
K161203 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 6d
Cleared May 03, 2016
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010,...
K152029 · BTT
Hamilton Medical AG
Anesthesiology · 286d
Cleared May 03, 2016
UCP COMPACT DRUG TESTS
K152908 · DKZ
Ucp Biosciences, Inc.
Toxicology · 215d
Cleared May 03, 2016
ENZA Zero-Profile Anterior Interbody Fusion
K153720 · OVD
Camber Spine Technologies
Orthopedic · 127d
Cleared May 03, 2016
SERFAS 90-S Electrosurgical Probe
K160050 · GEI
Stryker Corporation
General & Plastic Surgery · 113d
Cleared May 03, 2016
Swan Ganz Catheters
K160084 · DYG
Edwards Lifesciences, LLC
Cardiovascular · 109d
Cleared May 03, 2016
STROPP (Single Tunnel Repair of Plantar Plate)
K160118 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 105d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 36d
Cleared May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1,...
K160922 · MXZ
Dako North America, Inc.
Pathology · 29d
Cleared May 02, 2016
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
K151390 · LZC
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 342d
Cleared May 02, 2016
BTI Dental Implant System UnicCa
K151391 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 342d
Cleared May 02, 2016
HEX tanning booth
K152336 · LEJ
J & B Products Ltd Dba Hex Tanning
General & Plastic Surgery · 257d
Cleared May 02, 2016
Green Laser Photocoagulator GYC-500
K152603 · HQF
Nidek Co., Ltd.
Ophthalmic · 234d
Cleared May 02, 2016
Standard Clamp
K153358 · GDJ
Standard Bariatrics
General & Plastic Surgery · 164d
Cleared May 02, 2016
AirFit N20
K153673 · BZD
Resmed, Ltd.
Anesthesiology · 133d
Cleared May 02, 2016
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
K153745 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 125d
Cleared May 02, 2016
MX50T(MX50TQS)
K160354 · PGY
Wide Corporation
Radiology · 84d
Cleared May 02, 2016
TRINITY
K160357 · IYN
Koelis
Radiology · 84d
Cleared May 02, 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR...
K160609 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 60d
Cleared May 01, 2016
EndoFLIP
K160725 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 46d
Cleared May 01, 2016
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
K160960 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 29, 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with...
K152084 · LPH
Corentec Co., Ltd.
Orthopedic · 277d