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
27529–27552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2017
Aesculap Slim Clip Applier Forceps
K173271 · HCI
Aesculap, Inc.
Neurology · 29d
Cleared Nov 09, 2017
J2A SLA Dental Implant System
K161923 · DZE
Kj Meditech Co., Ltd.
Dental · 484d
Cleared Nov 09, 2017
FORTIFY Corpectomy Spacers
K162315 · MQP
Globus Medical, Inc.
Orthopedic · 448d
Cleared Nov 09, 2017
SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM...
K170071 · BXQ
Sleep Group Solutions
Anesthesiology · 304d
Cleared Nov 09, 2017
PROLIXUS TOTAL KNEE SYSTEM
K170534 · JWH
Otis Biotech Co., Ltd.
Orthopedic · 259d
Cleared Nov 09, 2017
Odyssey Micro Catheter
K170664 · DQY
Heraeus Medical Components, LLC
Cardiovascular · 248d
Cleared Nov 09, 2017
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +...
K170900 · FMF
Intervene Group, Ltd.
General Hospital · 227d
Cleared CT Nov 09, 2017
Geistlich Fibro-Gide
K171050 · NPL
Geistlich Pharma AG
Dental · 216d
Cleared Nov 09, 2017
ulrichINJECT CT motion
K171392 · IZQ
Ulrich GmbH & Co. KG
Cardiovascular · 182d
Cleared Nov 09, 2017
BioZorb Marker GOLD / LP Marker GOLD
K171467 · IYE
Focal Therapeutics
Radiology · 175d
Cleared Nov 09, 2017
Philips CT Big Bore
K171850 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared Nov 09, 2017
Medline ReNewal Reprocessed Synthes External Fixation Systems
K171911 · KTT
Surgical Instrument Service and...
Orthopedic · 136d
Cleared Nov 09, 2017
Alivio Ventricular Catheter and Flusher System (Alivio System)
K172006 · JXG
Alcyone Lifesciences, Inc.
Neurology · 129d
Cleared Nov 09, 2017
Televere Podiatry Digital Imaging System
K172124 · MQB
Televere Systems
Radiology · 118d
Cleared Nov 09, 2017
MX40 Release B.07
K172226 · MHX
Philips Medical Systems
Cardiovascular · 107d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · DQX
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Nov 09, 2017
OEC One
K172700 · OWB
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 63d
Cleared Nov 09, 2017
Aquarius 8600 1417WCI
K173273 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Nov 08, 2017
Dental High-speed Turbine Handpiece
K170229 · EFB
Guangdong Jinme Medical Technology...
Dental · 287d
Cleared Nov 08, 2017
C2 femoral stem
K170473 · LZO
Lima Corporate S.P.A.
Orthopedic · 265d
Cleared Nov 08, 2017
Stryker Universal Mesh
K170773 · JEY
Stryker
Dental · 239d
Cleared Nov 08, 2017
MHC Standard and NRFit Tip Syringes
K171131 · FMF
Mazza Healthcare, LLC
General Hospital · 205d
Cleared Nov 08, 2017
SurgicalPreview
K171534 · PZO
Endo Vantage, LLC
Cardiovascular · 167d