FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79489–79512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · DXE
Atrium Medical Corp.
Cardiovascular · 246d
Cleared Apr 26, 2001
EMBOL-X INTRODUCER, MODEL CF00200
K002973 · DYB
Embol-X, Inc.
Cardiovascular · 216d
Cleared Apr 26, 2001
SMARTSCREW MODEL 222006...227510
K003077 · HWC
Bionx Implants, Ltd.
Orthopedic · 205d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987 · JIN
Teco Diagnostics
Chemistry · 121d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
K004010 · LFR
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000...
K004046 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 118d
Cleared Apr 26, 2001
MAGNUM
K010252 · JFB
Magnum Equipment LLC
Physical Medicine · 90d