FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124945–124968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1990
SYNERMED GLUCOSE REAGENT KIT
K903063 · CGA
Synermed, Inc.
Chemistry · 66d
Cleared Sep 13, 1990
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · HBE
Micro-Aire Surgical Instruments, Inc.
Neurology · 30d
Cleared Sep 13, 1990
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K903884 · KWL
Kinamed, Inc.
Orthopedic · 23d
Cleared Sep 13, 1990
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K903885 · KWL
Kinamed, Inc.
Orthopedic · 23d
Cleared Sep 13, 1990
CALCIUM ARSENAZO III REAGENT
K903896 · CIC
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 13, 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007 · KHS
Amresco, Inc.
Chemistry · 15d
Cleared Sep 12, 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597 · FOZ
Vas-Cath, Inc.
General Hospital · 359d
Cleared Sep 12, 1990
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
K896892 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
K896893 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI BLOOD ADMINISTRATION SET
K896894 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET
K896895 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI SMALL VEIN INFUSION SET
K896896 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
DYNASTY HEARING SYSTEMS INSTRUMENT
K900632 · ESD
Alastair Granville-Jackson, Mfa, Ed.D.
Ear, Nose, Throat · 216d
Cleared Sep 12, 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966 · HGL
Hitachi Medical Corp. of America
Obstetrics & Gynecology · 195d
Cleared Sep 12, 1990
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156 · GNP
Granbio, Inc.
Microbiology · 183d
Cleared Sep 12, 1990
TRAUMA SLEEVE
K901509 · KME
Haz-Med, Inc.
General Hospital · 166d
Cleared Sep 12, 1990
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
K901840 · LJN
Granbio, Inc.
Microbiology · 141d
Cleared Sep 12, 1990
PROFESSIONAL MONITOR
K901907 · KPN
Travis Industries, Inc.
Gastroenterology & Urology · 138d
Cleared Sep 12, 1990
IV SET
K901949 · FPA
Jfv, Inc.
General Hospital · 135d
Cleared Sep 12, 1990
ALERT BED ALARM SYSTEM
K901969 · KMI
Alertronics, Inc.
General Hospital · 134d
Cleared Sep 12, 1990
ANOLIFT - PORTABLE & ANOLIFT - GANTRY
K902141 · FSA
Anodyne Corp.
General Hospital · 120d
Cleared Sep 12, 1990
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K902252 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 12, 1990
ZYMALAR IMPLANT
K902284 · LZK
Applied Biomaterial Technologies
General & Plastic Surgery · 113d
Cleared Sep 12, 1990
THE MAGNUM CHIN IMPLANT
K902285 · FWP
Applied Biomaterial Technologies
General & Plastic Surgery · 113d