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
40441–40464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237 · OQW
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 26, 2013
PROPARAFLU+ ASSAY
K132238 · OOU
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared Aug 23, 2013
VANISHPOINT BLOOD COLLECTION SET
K122355 · JKA
Retractable Technologies, Inc.
Chemistry · 385d
Cleared Aug 23, 2013
ACCUSONIC ADVANTAGE
K124010 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 239d
Cleared Aug 23, 2013
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
K130137 · ELC
Coltene/Whaledent
Dental · 217d
Cleared Aug 23, 2013
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K130244 · NBW
Delbio Incorporation
Chemistry · 204d
Cleared Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
K130268 · OUY
Becton, Dickinson & CO
Microbiology · 200d
Cleared Aug 23, 2013
MAGSTIM DOUBLE 70-2 COIL
K130403 · GWF
The Magstim Company , Ltd.
Neurology · 185d
Cleared Aug 23, 2013
CARDIODAY
K130516 · DQK
Getemed Medizin- Und...
Cardiovascular · 177d
Cleared Aug 23, 2013
PRE-FORMED GUIDEWIRES
K130798 · DQX
Lake Region Medical, Inc.
Cardiovascular · 154d
Cleared Aug 23, 2013
SUTTER BIPOLAR FORCEPS - SUPERGLISS
K131012 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 134d
Cleared Aug 23, 2013
TEMPUS(TM) CERVICAL PLATE SYSTEM
K131374 · KWQ
Neurostructures, LLC
Orthopedic · 102d
Cleared Aug 23, 2013
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
K131878 · NKB
Medyssey USA, Inc.
Orthopedic · 60d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978 · DQY
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 51d
Cleared Aug 23, 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K132268 · NEW
Surgical Specialties Corporation Dba...
General & Plastic Surgery · 32d
Cleared Aug 23, 2013
AUTOBAND LIGATOR
K132535 · MND
Endochoice, Inc.
Gastroenterology & Urology · 10d
Cleared Aug 22, 2013
POWDERED VINYL EXAMINATION GLOVES
K122100 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 402d
Cleared Aug 22, 2013
GIO DIGITAL PRESSURE GUAGES
K122627 · CAP
Galemed Corp.
Anesthesiology · 359d
Cleared Aug 22, 2013
WET PLATINUM PERSONAL LUBRICANT
K130012 · NUC
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 232d
Cleared Aug 22, 2013
DISPOSABLE NEUTRAL ELECTRODE GP202
K130027 · GEI
Cathay Manufacturing Corp.
General & Plastic Surgery · 231d
Cleared Aug 22, 2013
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
K130076 · EBI
Merz Dental GmbH
Dental · 220d
Cleared Aug 22, 2013
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
K130301 · KGO
Elimedical Devices (Fujian), Inc.
General Hospital · 196d
Cleared Aug 22, 2013
PROGIGY SUPPORT CATHETER
K130714 · DQY
Radius Medical, LLC
Cardiovascular · 160d