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
153025–153048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1984
TENDER LIFTING CARE
K840796 · FRZ
Lancer Assoc.
General Hospital · 57d
Cleared Apr 20, 1984
TOPS DISPOS. INFUSION SET/HEMODIALYSIS
K841119 · KNZ
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 36d
Cleared Apr 20, 1984
DIALYSIS TRAY
K841124 · KOC
Medcare Products
Gastroenterology & Urology · 36d
Cleared Apr 20, 1984
NCS RA LATEX TEST
K841146 · DHR
Ncs Diagnostics, Inc.
Immunology · 35d
Cleared Apr 20, 1984
RIM-BILE ESCULIN TEST
K841262 · JTO
Austin Biological Laboratories
Microbiology · 25d
Cleared Apr 20, 1984
RIM - NITRATE TEST
K841270 · JTO
Austin Biological Laboratories
Microbiology · 24d
Cleared Apr 20, 1984
RIM-HIPPURATE
K841277 · JTO
Austin Biological Laboratories
Microbiology · 23d
Cleared Apr 20, 1984
RIM 6.5% NACL
K841508 · JTO
Austin Biological Laboratories
Microbiology · 9d
Cleared Apr 19, 1984
DIGITAL SPHYGMOMANOMETER UA-231
K832721 · DXN
Copal, Inc.
Cardiovascular · 251d
Cleared Apr 19, 1984
ANTI-NATIVE DNA ANTIBODY
K834349 · KTL
Sigma Chemical Co.
Immunology · 128d
Cleared Apr 19, 1984
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · KRZ
American Dade
Hematology · 106d
Cleared Apr 19, 1984
RAPID IMMUNO-ASSAY SYS
K840257 · LLG
Applied Polytechnology, Inc.
Chemistry · 87d
Cleared Apr 19, 1984
PHASE II HCG KIT
K840328 · JHI
Medical & Scientific Designs, Inc.
Chemistry · 85d
Cleared Apr 19, 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603 · DTL
Shiley, Inc.
Cardiovascular · 69d
Cleared Apr 19, 1984
PLUS URINE HCG ASSAY
K840738 · JHJ
Monoclonal Antibodies, Inc.
Chemistry · 58d
Cleared Apr 19, 1984
KYOTEST UGK
K840829 · JIL
Kyoto Diagnostics, Inc.
Hematology · 55d
Cleared Apr 19, 1984
HIGH SPEED DISPENSER
K840938 · JQW
Micromedic Systems
Chemistry · 45d
Cleared Apr 19, 1984
LIQUID CHROMATOGRAPHIC DETECTOR LC-95
K840977 · KZR
The Perkin-Elmer Corp.
Toxicology · 44d
Cleared Apr 19, 1984
TRISACRYL GF 05 & TRISACRYL GF 2000
K840985 · DJY
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Apr 19, 1984
MATCHED COMPONENT SET RADIOIMMUNOASSAY
K841042 · CDZ
Cambridge Medical Technology
Chemistry · 38d
Cleared Apr 19, 1984
PARAMAX CHLORIDE REAGENT
K841047 · CHJ
American Dade
Toxicology · 38d
Cleared Apr 19, 1984
ACA DIGOXIN ANALYTICAL TEST PACK
K841107 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Apr 19, 1984
ACA DIGOXIN CALLIBRATOR
K841108 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Apr 19, 1984
P-S MEDICAL CSF-FLOW CONTROL VALVE-
K841442 · JXG
P-S Medical
Neurology · 13d