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

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174,955 results
99289–99312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1996
HEMO-BARRIER
K953500 · KMF
Asia Dynamics, Inc.
General & Plastic Surgery · 182d
Cleared Jan 24, 1996
MIRACLE EAR MIRAGE
K954119 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 145d
Cleared Jan 24, 1996
STEALTHSTATION
K954276 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 133d
Cleared Jan 24, 1996
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K954332 · CGN
Bayer Corp.
Chemistry · 128d
Cleared Jan 24, 1996
MALLINCKRODT SHILEY 15MM CAP
K954749 · JOH
Mallinckrodt Medical
Anesthesiology · 100d
Cleared Jan 24, 1996
EZ FIX
K954838 · JEC
Biodynamic Technologies, Inc.
Orthopedic · 96d
Cleared Jan 24, 1996
STERILE WATER O.9% STERILE SALINE
K954887 · FOZ
Lockett Medical Corp.
General Hospital · 100d
Cleared Jan 24, 1996
OMEGA ULTRASCAN
K954911 · GEX
Gyne-Tech Instrument Corp.
General & Plastic Surgery · 91d
Cleared Jan 24, 1996
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · FIP
Better Water, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 24, 1996
LYELL SOUND
K954972 · FBS
Venture Management Corp.
Gastroenterology & Urology · 89d
Cleared Jan 24, 1996
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
K954997 · JOZ
Centocor, Inc.
Hematology · 84d
Cleared Jan 24, 1996
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052 · KGE
Olympus America, Inc.
Gastroenterology & Urology · 79d
Cleared Jan 24, 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K955065 · FCL
Olympus America, Inc.
Gastroenterology & Urology · 79d
Cleared Jan 24, 1996
MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
K955149 · BYY
Bio-Medical Devices, Inc.
General Hospital · 72d
Cleared Jan 24, 1996
MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
K955151 · BYY
Bio-Medical Devices, Inc.
General Hospital · 72d
Cleared Jan 24, 1996
DISSECTION PROBE
K955163 · GEI
Origin Medsystems, Inc.
General & Plastic Surgery · 72d
Cleared Jan 24, 1996
ACCULUPE
K955184 · LMB
E For M Imaging Systems Div.,...
Radiology · 72d
Cleared Jan 24, 1996
GALLOY
K955285 · EJJ
Southern Dental Industries, Inc.
Dental · 68d
Cleared Jan 24, 1996
ALTERNATIVE STERILIZATION PROCESS
K955354 · JDI
Howmedica Corp.
Orthopedic · 64d
Cleared Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Jan 24, 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K955494 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared Jan 24, 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · DIH
Diagnostic Chemicals , Ltd.
Toxicology · 54d
Cleared Jan 24, 1996
ALPHA-DENT COPAL CAVITY VARNISH
K955521 · LBH
Wallace A. Erickson & Co.
Dental · 51d