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
152809–152832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1984
BIERMAN BIOPSY NEEDLE
K841299 · GDM
Popper & Sons, Inc.
General & Plastic Surgery · 33d
Cleared May 02, 1984
DIRECTIGEN MENNINGITIS TEST KIT
K841308 · GTI
Bd Becton Dickinson Vacutainer...
Microbiology · 33d
Cleared May 02, 1984
SPC ARTHROSCOPY TABLE
K841328
Surgical Products Corp.
General & Plastic Surgery · 50d
Cleared May 02, 1984
RIM ONPG KIT
K841329 · JTO
Austin Biological Laboratories
Microbiology · 30d
Cleared May 02, 1984
PROGESTERONE DIRECT RIA KIT-RADIOIMM
K841333 · JLS
Biotecx Laboratories, Inc.
Chemistry · 30d
Cleared May 02, 1984
LARYNGEAL STENT
K841347 · FWN
E. Benson Hood Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 02, 1984
UMBRELLA KEEL
K841348
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 30d
Cleared May 02, 1984
ND1200 RIA COUNTER
K841352 · JJJ
Nuclear Data, Inc.
Chemistry · 30d
Cleared May 02, 1984
WELLCOGEN S. PNEUMONIAE
K841376 · GWC
Wellcome Diagnostics
Microbiology · 29d
Cleared May 02, 1984
VENT-WELL VENTILATOR TUBING
K841378 · BZO
Airmed Corp.
Anesthesiology · 29d
Cleared May 02, 1984
RIM-DNASE KIT
K841389 · JSF
Austin Biological Laboratories
Microbiology · 29d
Cleared May 02, 1984
CODE-A-WELL
K841390 · LIB
Plastic Injectors, Inc.
Microbiology · 29d
Cleared May 02, 1984
DIFFERENTIATION DISKS SPECTINOMYCIN
K841453 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared May 02, 1984
RIM GARDNERELLA VAGINALIS KIT
K841460 · JTO
Austin Biological Laboratories
Microbiology · 23d
Cleared May 02, 1984
COAGULATION CONTROL PLASMA LEVEL 1/2/3
K841461 · GGP
Diatech, Inc.
Hematology · 23d
Cleared May 02, 1984
DECALCIFIER I
K841488 · KDX
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared May 02, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES
K841532 · LFG
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 16d
Cleared May 02, 1984
MODEL 3000 HYPERBARIC CHAMBER
K841608 · CBF
Custom Craft Products, Inc.
Anesthesiology · 13d
Cleared May 02, 1984
THREE PORT SENSOR MANIFOLD
K841637 · BZO
Dryden Corp.
Anesthesiology · 12d
Cleared May 01, 1984
LONG TERM CENTRAL VENOUS ACCESS CATH
K834299 · LJS
Burron Medical Products, Inc.
General Hospital · 145d
Cleared May 01, 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 141d
Cleared May 01, 1984
DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT
K834383 · LJS
Burron Medical Products, Inc.
General Hospital · 139d
Cleared May 01, 1984
GELSCAN SOFTWARE 2190
K834490 · JQP
Lkb Instruments, Inc.
Chemistry · 147d
Cleared May 01, 1984
BIOCERAM ZEST PLANT
K840244 · DZE
Zest Anchors, Inc.
Dental · 102d