FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164089–164112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1981
SKIN SCRUB TRAY
K810558 · HFD
Associated Medical Products Co.
Obstetrics & Gynecology · 15d
Cleared Mar 17, 1981
OPTI- SYSTEM
K810559 · BTT
Corpak Co.
Anesthesiology · 14d
Cleared Mar 17, 1981
TN-3000 EVOKED RESPONSE SYSTEM
K810560 · GWF
Tracor Northern, Inc.
Neurology · 14d
Cleared Mar 17, 1981
CARBON DIOXIDE (C02) MICROSURGICAL LASER
K810562 · HHR
Metricon, Ltd.
Obstetrics & Gynecology · 14d
Cleared Mar 17, 1981
QUINTON LTE ELECTRODE
K810563 · DRX
Quinton, Inc.
Cardiovascular · 14d
Cleared Mar 17, 1981
PARAFFIN EMBEDDING MEDIUM
K810568 · KEO
Surgipath Medical Industries, Inc.
Radiology · 14d
Cleared Mar 17, 1981
MARTIN TRACH-SECURE
K810575 · BTO
Diatek, Inc.
Anesthesiology · 14d
Cleared Mar 17, 1981
EARETTE HEARING AID(BEHING THE EAR)
K810576 · ESD
Oticon Corp.
Ear, Nose, Throat · 14d
Cleared Mar 17, 1981
FACT* HOME PREGNANCY TEST
K810581 · JHJ
Ortho Pharmaceutical Corp.
Chemistry · 14d
Cleared Mar 17, 1981
EMIT-TFG PRISMA THYROXINE ASSAY
K810586 · KLI
Syva Co.
Chemistry · 13d
Cleared Mar 17, 1981
CENTRIFI CHEM SYSTEM 400 ANALYZER
K810596 · JJE
Union Carbide Corp.
Chemistry · 11d
Cleared Mar 17, 1981
MACRO-VUE CARD TEST
K810597 · KLB
Bd Becton Dickinson Vacutainer...
Toxicology · 11d
Cleared Mar 17, 1981
EMIT-ST SERUM PHENCYCLIDINE ASSAY
K810601 · LCM
Syva Co.
Toxicology · 11d
Cleared Mar 17, 1981
CORNING 925 CHLORIDE METER
K810615 · JFS
Corning Medical & Scientific
Chemistry · 8d
Cleared Mar 17, 1981
HOLLISTER MALE URINARY INCONT. SYSTEM
K810708
Hollister, Inc.
Gastroenterology & Urology
Cleared Mar 16, 1981
NEMECTRODYN 8
K802804 · IPF
Nemectron Medical, Inc.
Physical Medicine · 131d
Cleared Mar 16, 1981
ELITE
K810246 · IPF
Bloomex International, Inc.
Physical Medicine · 46d
Cleared Mar 13, 1981
THROMBO-TEST (X)
K801054 · JPK
Medtro GmbH
Hematology · 312d
Cleared Mar 13, 1981
DOUBLE LUMEN TRACHEAL TUBE
K802505 · BTR
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 149d
Cleared Mar 13, 1981
KPP PERITONEAL DIALYSATE FILTER
K803275 · KPP
Millipore Corp.
Gastroenterology & Urology · 74d
Cleared Mar 13, 1981
MIROMED PERITONEAL DIALYSIS CATHETER
K810236 · FJS
American Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 13, 1981
VESSEL TIPS, SIZES 13-18
K810257 · FKW
Quinton, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 13, 1981
DATASON DB ULTRASOUND IMAGING SYSTEM
K810305 · HEM
General Electric Co.
Obstetrics & Gynecology · 36d
Cleared Mar 13, 1981
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · DTB
Medtronic Vascular
Cardiovascular · 32d