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
141793–141816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1986
NATURAL DETECTOR SYSTEM
K861731 · KHE
U.S. Health Resources Corp.
Hematology · 184d
Cleared Nov 06, 1986
PIASTRINIT
K863114 · GGK
J. D. Assoc.
Hematology · 85d
Cleared Nov 06, 1986
AMICON DIAFILTER HEMOFILTER
K863823 · KDI
Amicon, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 06, 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · FKP
Gambro, Inc.
Gastroenterology & Urology · 17d
Cleared Nov 06, 1986
PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)
K864167
Datascope Corp.
Cardiovascular · 13d
Cleared Nov 06, 1986
FRESENIUS HEMOFLOW F50 & F70
K864169 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 05, 1986
MONO ACU-SLIDE TEST
K861211 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 219d
Cleared Nov 05, 1986
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · DZE
Core-Vent Corp.
Dental · 203d
Cleared Nov 05, 1986
SERUM CLONAZEPAM TOXICOLOGY CONTROL
K862421 · LAS
Utak Laboratories, Inc.
Toxicology · 133d
Cleared Nov 05, 1986
OXOID SIGNAL BLOOD CULTURE SYSTEM
K862946 · JSG
Oxoid U.S.A., Inc.
Microbiology · 92d
Cleared Nov 05, 1986
UNIDEX GLUCOSE TEST STRIP
K862984 · CGA
Unidex, Inc.
Chemistry · 90d
Cleared Nov 05, 1986
THEOFAST(TM) TEST PACKAGE
K863475 · LER
3M Company
Chemistry · 57d
Cleared Nov 05, 1986
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Nov 05, 1986
LYTENING 2
K863521 · JGS
Amdev, Inc.
Chemistry · 56d
Cleared Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Nov 05, 1986
HCG CONTROL KIT
K863744 · JJX
Monoclonal Antibodies, Inc.
Chemistry · 42d
Cleared Nov 05, 1986
VMAX KINETIC MICROPLATE READER
K863802 · JJQ
Molecular Devices Corp.
Chemistry · 37d
Cleared Nov 05, 1986
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Nov 05, 1986
SMI MULTIPETTOR(TM)
K863887 · JQW
American Dade
Chemistry · 30d
Cleared Nov 05, 1986
DU PONT PHENYTOIN ASSAY AND CALIBRATOR
K863888 · DIR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 30d
Cleared Nov 05, 1986
WIDEX HEARING AID MODEL ES2
K864097 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 15d
Cleared Nov 05, 1986
LIGACLIP 20/20* MULTIPLE CLIP APPLIER
K864102 · FZP
Ethicon, Inc.
General & Plastic Surgery · 15d
Cleared Nov 05, 1986
RANFAC CUT BIOPSY NEEDLE
K864139 · GAA
Ranfac, Corp.
General & Plastic Surgery · 14d
Cleared Nov 05, 1986
DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)
K864146 · GDW
Cardio Thoracic Systems
General & Plastic Surgery · 14d