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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80089–80112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD...
K010835 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 41d
Cleared Apr 30, 2001
SIMPLICITY WING INFUSION SET
K010886 · FPA
Sterling Medivations, Inc.
General Hospital · 38d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · ODD
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 27, 2001
SENOJ IMPLANT SYSTEM
K000889 · DZE
Senoj Biocare, Inc.
Dental · 403d
Cleared Apr 27, 2001
GRAFT MARKER RING
K001915 · MAB
T. Korossurgical Instruments Corp.
Cardiovascular · 308d
Cleared Apr 27, 2001
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
K003325 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 185d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · HRX
Aesculap, Inc.
Orthopedic · 144d
Cleared Apr 27, 2001
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K010178 · LTZ
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 98d
Cleared Apr 27, 2001
HANSATOME MICROKERATOME
K010260 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Apr 27, 2001
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND...
K010264 · FIB
Nipro Medical Corp.
Gastroenterology & Urology · 88d
Cleared Apr 27, 2001
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Apr 27, 2001
DRYSTAR 4500 PRINTER, MODEL 4500
K010275 · LMC
Agfa Medical Imaging
Radiology · 87d
Cleared Apr 27, 2001
MED-LOGICS DISPOSABLE ALK TUBING
K010353 · KYG
Med-Logics, Inc.
Ophthalmic · 80d
Cleared Apr 27, 2001
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE...
K010371 · HIS
Suretex, Ltd.
Obstetrics & Gynecology · 79d
Cleared Apr 27, 2001
CEDARS-SINAI BPGS AND MOCO
K010509 · KPS
Smv America
Radiology · 65d
Cleared Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529 · JDI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 27, 2001
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
K010662 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 57d
Cleared Apr 27, 2001
TRANSAMERICA DIGITAL EMS
K010665 · IPF
Transamerica Medical Systems
Physical Medicine · 52d
Cleared Apr 27, 2001
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · FTL
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared Apr 27, 2001
TRANSAMERICAN TENS
K010782 · GZJ
Transamerica Medical Systems
Neurology · 43d
Cleared Apr 27, 2001
CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1,...
K010789 · GCJ
A & A Medical, Inc.
General & Plastic Surgery · 43d
Cleared Apr 27, 2001
SPAZZ
K010823 · IOR
Colours 'N Motion
Physical Medicine · 39d
Cleared Apr 27, 2001
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
K011016 · GCJ
Lsi Solutions
General & Plastic Surgery · 23d
Cleared Apr 27, 2001
SONICAID SYSTEM 8002
K992607 · HGM
Oxford Instruments Medical Systems
Obstetrics & Gynecology · 633d