Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
40729–40752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2013
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
K131542 · FRO
Novabay Pharmaceuticals, Inc.
General & Plastic Surgery · 56d
Cleared Jul 24, 2013
SAM JUNCTIONAL TOURNIQUET
K131561 · DXC
Sam Medical Products
Cardiovascular · 55d
Cleared Jul 24, 2013
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Jul 24, 2013
HEM-6131
K131742 · DXN
Omron Healthcare, Inc.
Cardiovascular · 41d
Cleared Jul 24, 2013
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · DWA
Medtronic, Inc.
Cardiovascular · 27d
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Philips Health Care
Radiology · 19d
Cleared Jul 23, 2013
MFP-051
K123631 · EBF
GC America, Inc.
Dental · 242d
Cleared Jul 23, 2013
SHARPSCAN
K123807 · MMK
Medical Engineering Development...
General Hospital · 224d
Cleared Jul 23, 2013
SPACELABS HEALTHCARE CARDIOEXPRESS
K130207 · DPS
Spacelabs Healthcare, Ltd.
Cardiovascular · 176d
Cleared Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
K130648 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 134d
Cleared Jul 23, 2013
AIRSONETT AIR-4
K130702 · FRF
Airsonett AB
General Hospital · 130d
Cleared Jul 23, 2013
NIGHTINGALE MONITORING SYSTEM
K130740 · MWI
Zoe Medical, Inc.
Cardiovascular · 126d
Cleared Jul 23, 2013
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
K130862 · ELC
Dentsply Intl., Inc.
Dental · 117d
Cleared Jul 23, 2013
FRAG-LOC SYSTEM
K130986 · HTN
Acumed, LLC
Orthopedic · 105d
Cleared Jul 23, 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 33d
Cleared Jul 23, 2013
ULTRAEXTEND USWS-900A V2.1 AND V3.1
K131822 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Jul 23, 2013
ESIE APPS SUITE
K132062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 22, 2013
MR CONDITIONAL PRESSON ELECTRODE
K130220 · GXZ
Rhythmlink International, LLC
Neurology · 174d
Cleared CT Jul 22, 2013
RHYTHMIA MAPPING SYSTEM
K130750 · DQK
Rhythmia Medical, Inc.
Cardiovascular · 125d
Cleared Jul 22, 2013
4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL...
K131191 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 87d
Cleared Jul 22, 2013
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
K131306 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 76d
Cleared Jul 22, 2013
MICRO AMBULATORY ECG RECORDER
K131572 · DPS
Dimetek Digital Medical Technologies,...
Cardiovascular · 52d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418 · JSS
Advandx, Inc.
Microbiology · 257d
Cleared Jul 19, 2013
TRANSCEND
K120510 · GEI
Syneron Medical, Ltd.
General & Plastic Surgery · 514d