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
52009–52032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 2009
ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030,...
K092616 · KLE
CAO Group, Inc.
Dental · 56d
Cleared Oct 21, 2009
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
K092824 · MSH
Alpha Protech, Inc.
General Hospital · 37d
Cleared Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 33d
Cleared Oct 21, 2009
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
K092887 · NBW
Eps Bio Technology Corp.
Chemistry · 30d
Cleared Oct 21, 2009
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K092957 · OCC
Nanosphere, Inc.
Microbiology · 26d
Cleared Oct 21, 2009
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
K093116 · PSZ
Response Biomedical Corp.
Microbiology · 19d
Cleared Oct 20, 2009
LENSTAR, MODEL LS900
K082891 · HJO
Haag-Streit AG
Ophthalmic · 385d
Cleared Oct 20, 2009
OMNI 2 OXYGEN SYSTEM
K083163 · CAW
Sequal Technologies, Inc.
Anesthesiology · 358d
Cleared Oct 20, 2009
POLY-CHEM 90 GLUCOSE
K090703 · CFR
Polymedco, Inc.
Chemistry · 217d
Cleared Oct 20, 2009
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
K091542 · DWF
Endoscopic Technologies, Inc. D/B/A...
Cardiovascular · 147d
Cleared Oct 20, 2009
ALCON ULTRACHOPPER
K091777 · HQC
Alcon Research, Ltd.
Ophthalmic · 125d
Cleared Oct 20, 2009
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 20, 2009
EMS AIR-FLOW HANDY PERIO
K092289 · EFB
E.M.S Electro Medical Systems S.A
Dental · 83d
Cleared Oct 20, 2009
REJUVENATE MODULAR STEM
K092561 · MEH
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Oct 19, 2009
DISTRACTABLE WAVE CAGE
K083626 · MAX
Advanced Medical Technology, Inc.
Orthopedic · 315d
Cleared Oct 19, 2009
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
K090474 · ONN
Orthosensor, Inc.
Orthopedic · 237d
Cleared Oct 19, 2009
DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER,...
K090487 · DXT
Coeur, Inc.
Cardiovascular · 236d
Cleared Oct 19, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
K092034 · LZA
Pt. Smartglove Indonesia
General Hospital · 105d
Cleared Oct 19, 2009
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K092895 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Oct 19, 2009
CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
K092898 · MAI
Conmed Linvatec
Orthopedic · 28d
Cleared Oct 16, 2009
THAI NIPPON MALE LATEX CONDOM
K081265 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 529d
Cleared Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
K083260 · DDR
Roche Diagnostics
Chemistry · 345d
Cleared Oct 16, 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · EFB
J. Morita USA, Inc.
Dental · 185d
Cleared Oct 16, 2009
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
K091516 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 147d