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
151009–151032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1984
DILATOR/SHEATH SET
K842632 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 88d
Cleared Oct 02, 1984
AMER. EDWARDS LAB DIAFLEX URETERAL DILA
K842639 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Oct 02, 1984
ESOPHAGEAL DILATOR SET
K842679 · FAT
Mill-Rose Laboratory
Gastroenterology & Urology · 84d
Cleared Oct 02, 1984
LASER FOR GENITOURINARY APPLIC. 4000
K843240 · LNK
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 41d
Cleared Oct 02, 1984
ND-YAG LASER FOR UROLOGICAL SURGERY
K843293 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 02, 1984
ND-YAG LASER FOR PALLIATION OF GI MALIGN
K843374 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 02, 1984
HARRIS HEMATOXYLIN, MERCURY FREE, ACID
K843425 · HYK
Accra Laboratories, Inc.
Pathology · 28d
Cleared Oct 02, 1984
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
K843427 · HZJ
Accra Laboratories, Inc.
Pathology · 28d
Cleared Oct 02, 1984
NEOMYCIN BLOOD AGAR
K843492 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Oct 02, 1984
DIFFERENTIATION DISKS NITRATE
K843521 · JTO
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Oct 02, 1984
TSH QUIK RIA KIT
K843545 · JLW
Pacific Biotech, Inc.
Chemistry · 22d
Cleared Oct 01, 1984
E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
K842121 · LJE
E-Z-Em, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 01, 1984
GORE-TEX VASCULAR GRAFT, FEP-RINGED
K842144 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 124d
Cleared Oct 01, 1984
AMERICAN MEDICAL OPTICS I/A KIT- IRRIG
K842197 · HQE
American Medical Optics
Ophthalmic · 119d
Cleared Oct 01, 1984
MICROMEDICS SURGICAL INSTRUMENTS
K842212
Micromedics, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 01, 1984
SUR-FIT IRRIGATION ADAPTER FACEPLATE
K842398 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 104d
Cleared Oct 01, 1984
AMER. MEDICAL OPTICS DIGITAL KERATO-
K842504 · HQL
American Medical Optics
Ophthalmic · 97d
Cleared Oct 01, 1984
AMIZYME-C TRACHOMATIS TEST KIT
K842525 · LJP
Amico Lab, Inc.
Immunology · 95d
Cleared Oct 01, 1984
VON WILLEBRAND FACTOR ANTIGEN SCREEN
K842537 · ICF
American Dade
Hematology · 95d
Cleared Oct 01, 1984
VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT
K842617 · GGP
American Dade
Hematology · 88d
Cleared Oct 01, 1984
EPSILON HCG TEST KIT MONOCLONAL
K842654 · JHI
Beckman Instruments, Inc.
Immunology · 83d
Cleared Oct 01, 1984
ANTI-CHLAMYDIA TRACHOMATIS KIT
K842658 · LJP
Amico Lab, Inc.
Immunology · 83d
Cleared Oct 01, 1984
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · GKH
R&D Systems, Inc.
Hematology · 80d
Cleared Oct 01, 1984
FORMALIN BUFFERED
K842982 · IFP
Reagent Laboratory, Inc.
Pathology · 63d