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
144313–144336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1986
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K860367 · JGF
Alpkem Corp.
Chemistry · 67d
Cleared Apr 11, 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · KHQ
American Dade
Chemistry · 66d
Cleared Apr 11, 1986
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · LDJ
Syva Co.
Toxicology · 59d
Cleared Apr 11, 1986
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
K860525 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 59d
Cleared Apr 11, 1986
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Apr 11, 1986
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
K860663 · JHY
Amresco, Inc.
Chemistry · 46d
Cleared Apr 11, 1986
DAHLBERG MODEL UT IN-THE-EAR HEARING AID
K860670 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Apr 11, 1986
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL)
K860717 · CHH
Trace Scientific , Ltd.
Chemistry · 44d
Cleared Apr 11, 1986
CHARISMA HEARING AID
K860759 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 11, 1986
SICKLE CELL REAGENT SET
K860812 · GHM
Michclone Associates, Inc.
Hematology · 38d
Cleared Apr 11, 1986
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · JTN
Organon Teknika Corp.
Microbiology · 32d
Cleared Apr 11, 1986
THERACHEM, TDC THERAPEUTIC DRUG CONTROLS
K860919 · DIF
Fisher Scientific Co., LLC
Toxicology · 31d
Cleared Apr 11, 1986
EXEL DENTAL NEEDLE
K861150 · DZM
Exel Intl.
Dental · 16d
Cleared Apr 11, 1986
FORMALDEHYDE SOLUTION, 37%
K861201 · IGG
Surgipath Medical Industries, Inc.
Pathology · 11d
Cleared Apr 11, 1986
ORTHOSOURCE ETCH SYSTEMS
K861245 · EBC
Ortho Source
Dental · 9d
Cleared Apr 11, 1986
TISSUE CULTURE FLASK PL 732 PLASTIC
K861253 · KJA
Travenol Laboratories, S.A.
Pathology · 8d
Cleared Apr 11, 1986
MACCONKEY W/MUG
K861259 · JTO
Remel Co.
Microbiology · 8d
Cleared Apr 11, 1986
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
K861270 · KEO
Surgipath Medical Industries, Inc.
Pathology · 7d
Cleared Apr 11, 1986
GAS SAMPLING KIT
K861286 · BZO
Respiratory Support Products, Inc.
Anesthesiology · 4d
Cleared Apr 11, 1986
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
K861330 · CAP
Sechrist Industries, Inc.
Anesthesiology · 2d
Cleared Apr 10, 1986
THRUST-AIRE MODEL 2001
K860618
Charron Industries, Inc.
Physical Medicine · 50d
Cleared Apr 10, 1986
BARD ABSORPTION DRESSING
K861024 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Apr 09, 1986
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
K853663 · LPZ
Travenol Laboratories, S.A.
General Hospital · 218d
Cleared Apr 09, 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · KHE
Self Care Systems, Inc.
Chemistry · 162d