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
125617–125640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · JFJ
Catachem, Inc.
Chemistry · 68d
Cleared Jul 31, 1990
NF-50-E DISPOSABLE ECG ELECTRODE
K902407 · DRX
Medicotest, Inc.
Cardiovascular · 61d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661 · GQL
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662 · GQL
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jul 31, 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 42d
Cleared Jul 31, 1990
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K902776 · JJQ
Slt Labinstruments, Inc.
Chemistry · 36d
Cleared Jul 31, 1990
RUBELLA IGG
K902793 · LFX
Pharmacia Diagnostics, Inc.
Microbiology · 35d
Cleared Jul 31, 1990
VISI-DRAPE OPHTHALMIC DRAPES
K902857 · HMY
Visitec Co.
Ophthalmic · 32d
Cleared Jul 31, 1990
SYNERMED SERUM IRON REAGENT KIT
K902918 · CFM
Synermed, Inc.
Chemistry · 28d
Cleared Jul 31, 1990
SYNERMED MAGNESIUM REAGENT KIT
K902919 · JGJ
Synermed, Inc.
Chemistry · 28d
Cleared Jul 31, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K903000 · JHR
Ventrex Laboratories, Inc.
Immunology · 22d
Cleared Jul 30, 1990
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
K896787 · GZJ
Saratoga Intl., Inc.
Neurology · 238d
Cleared Jul 30, 1990
MUSTANG, C.A.T.
K901957 · EJF
Lancer Orthodontics, Inc.
Dental · 90d
Cleared Jul 30, 1990
GUARDIAN SAFE BOW
K901958 · DZB
Lancer Orthodontics, Inc.
Dental · 90d
Cleared Jul 30, 1990
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
K902312 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 68d
Cleared Jul 30, 1990
PM14 SOFT AIR COMPRESSOR
K902762 · BTI
Precision Medical, Inc.
Anesthesiology · 35d
Cleared Jul 30, 1990
OPUS TM T-UPTAKE TEST SYSTEM
K902797 · KHQ
Pb Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Jul 30, 1990
THOMPSON TYPE HIS PROSTHESIS
K903240 · KWL
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
AUSTIN MOORE TYPE HIP PROSTHESIS
K903241 · KWL
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
ACETABULAR CUP
K903242 · JDI
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
MULLER-TYPE FEMORAL COMPONENT
K903243 · JDI
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
LAG SCREW
K903244 · HWC
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
SIDE PLATE
K903246 · KTT
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
ADJUSTABLE ANGLE GUIDE
K903247 · LXH
Onyx Medical Corp.
Orthopedic · 6d