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
146953–146976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1985
HILLCREST AMEBIASIS IHA TEST
K853448 · KHW
Hillcrest Biologicals
Microbiology · 12d
Cleared Aug 28, 1985
LX EMBEDDING CENTER
K853463
Innovative Medical Systems, Inc.
Pathology · 9d
Cleared Aug 28, 1985
STAPH KIT
K853488 · JSI
Culture Kits, Inc.
Microbiology · 8d
Cleared Aug 28, 1985
PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
K853497 · IFP
Surgipath Medical Industries, Inc.
Pathology · 8d
Cleared Aug 28, 1985
ORTHO VIRAL TRANSPORT
K853500 · JSM
Ortho Diagnostic Systems, Inc.
Microbiology · 8d
Cleared Aug 27, 1985
O.M.S. UV-COLOURS
K851410 · HQG
Optical Moulding Systems
Ophthalmic · 140d
Cleared Aug 27, 1985
URI-SURE
K852619 · KNX
Ashai Co. , Ltd.
Gastroenterology & Urology · 68d
Cleared Aug 27, 1985
LAURIER SAFETY LONG SANITORY NAPKIN
K852924 · HHD
Kao Corp.
Obstetrics & Gynecology · 49d
Cleared Aug 27, 1985
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · FCW
Welch Allyn, Inc.
Gastroenterology & Urology · 47d
Cleared Aug 27, 1985
ENTERAL FEEDING CONTAINER
K852966 · KNT
Empire Industries, Inc.
Gastroenterology & Urology · 46d
Cleared Aug 27, 1985
P.A. ENTERAL FEEDING BAG 1100
K853309 · KNT
Pa Medical Corp.
Gastroenterology & Urology · 20d
Cleared Aug 27, 1985
H-H SEXTON SCUP URINE MGMT. SYS
K853458 · KNX
Holter-Hausner Intl.
Gastroenterology & Urology · 11d
Cleared Aug 26, 1985
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · DQY
Quinton, Inc.
Cardiovascular · 55d
Cleared Aug 26, 1985
LAURIER OVERNIGHT SANITARY NAPKIN
K852922 · HHD
Kao Corp.
Obstetrics & Gynecology · 48d
Cleared Aug 26, 1985
PHOENIX ANESTHESIA MACHINE
K853139 · BSZ
American Anesthesia, Inc.
Anesthesiology · 38d
Cleared Aug 26, 1985
ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
K853265
Geneva Laboratories, Inc.
General & Plastic Surgery · 21d
Cleared Aug 26, 1985
FETAL BOVINE SERUM IN TRANSFER CONTAINER
K853441 · KJA
Newport Biosystems, Inc.
Pathology · 13d
Cleared Aug 23, 1985
CHERMEL SCALP VEIN SET
K851516 · FPA
Cher Mel Corp.
General Hospital · 130d
Cleared Aug 23, 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · CGA
Miles Laboratories, Inc.
Chemistry · 121d
Cleared Aug 23, 1985
UNSCENTED MENSTRUAL TAMPONS
K851941 · HEB
Personal Products Co.
Obstetrics & Gynecology · 112d
Cleared Aug 23, 1985
ALLOY 7
K852093 · EJS
Williams Gold Refining Co., Inc.
Dental · 101d
Cleared Aug 23, 1985
MODEL 451 CO2 SURGICAL LASER
K852190 · GEX
Coherent Medical Group
General & Plastic Surgery · 93d
Cleared Aug 23, 1985
DENTOLOCK II DENTURE ADHESIVE CREAM
K852926
Solar Dental Co., Inc.
Dental · 45d
Cleared Aug 23, 1985
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095 · GCX
Boehringer Laboratories
General Hospital · 31d