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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96313–96336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1996
SIGNALDRESS
K962590 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 80d
Cleared Sep 20, 1996
ESTEEM 1.5T MRI SYSTEM
K962677 · LNH
Elscint Mr, Inc.
Radiology · 73d
Cleared Sep 20, 1996
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806 · FMZ
Ohmeda Medical
General Hospital · 64d
Cleared Sep 20, 1996
KODAK DIGITAL SCIENCE REMOTE CASSETTE
K962896 · KPR
Eastman Kodak Company
Radiology · 57d
Cleared Sep 20, 1996
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
K962986 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 50d
Cleared Sep 20, 1996
SCION SAPHENOUS VEIN HARVESTING SYSTEM
K963006 · GAD
Scion International, Inc.
General & Plastic Surgery · 49d
Cleared Sep 20, 1996
ENDOSPOT
K963043 · FCW
Corin USA
Gastroenterology & Urology · 46d
Cleared Sep 20, 1996
ENDOBEAM
K963044 · GCT
Corin USA
Gastroenterology & Urology · 46d
Cleared Sep 20, 1996
TBAN
K963252 · EOQ
Boston Scientific Corp
Ear, Nose, Throat · 32d
Cleared Sep 20, 1996
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL
K963607 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 11d
Cleared Sep 19, 1996
CONTRAST INJECTION LINES
K960674 · DXT
B.Braun Medical, Inc.
Cardiovascular · 212d
Cleared Sep 19, 1996
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
K961716 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 140d
Cleared Sep 19, 1996
TSH (MICROWELL) ELISA
K962216 · JLW
Biomerica, Inc.
Chemistry · 101d
Cleared Sep 19, 1996
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
K962402 · HQC
Allergan, Inc.
Ophthalmic · 90d
Cleared Sep 19, 1996
PRIMALOC CEMENTED HIP SYSTEM
K962448 · KWY
Ortho Development Corp.
Orthopedic · 87d
Cleared Sep 19, 1996
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
K962525 · LFL
Morwel Corp.
General & Plastic Surgery · 84d
Cleared Sep 19, 1996
VITALITY HIP STEM
K962560 · JDI
Encore Orthopedics, Inc.
Orthopedic · 80d
Cleared Sep 19, 1996
ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE
K962692 · GEI
Zomed Intl.
General & Plastic Surgery · 70d
Cleared Sep 19, 1996
ON.SITE ALCOHOL
K963197 · DML
Ansys, Inc.
Toxicology · 35d
Cleared Sep 18, 1996
CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
K953663 · DRF
Cordis Webster, Inc.
Cardiovascular · 408d
Cleared Sep 18, 1996
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061 · HQE
Storz Instrument Co.
Ophthalmic · 258d
Cleared Sep 18, 1996
SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
K960754 · QGH
Mecta Corp.
Neurology · 208d
Cleared Sep 18, 1996
GONOPOX TEST KIT
K960759 · JSX
Medtex Laboratories, Inc.
Microbiology · 205d
Cleared Sep 18, 1996
10B ARGININE BROTH
K961046 · JSM
Remel, L.P.
Microbiology · 187d