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
155497–155520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1983
KEMTEK 104 RIA GAMMA COUNTER
K832736 · JJJ
Kemble Instruments, Inc.
Chemistry · 52d
Cleared Sep 29, 1983
ECT PROCESSOR
K832737 · JWM
Siemens Gammasonics, Inc.
Radiology · 49d
Cleared Sep 29, 1983
HEYER-SCHULTE AFTERLOADING CATHETER
K832738 · IWJ
American Heyer Schulte
Radiology · 48d
Cleared Sep 29, 1983
BEHIND-THE-EAR SERIES 125
K832751 · ESD
Danavox, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 29, 1983
MILLER/NADLER GLARE TESTER
K832762 · HLX
Titmus Optical, Inc.
Ophthalmic · 44d
Cleared Sep 29, 1983
AMES TDA DISOPYRAMIDE TEST
K832766 · KLT
Miles Laboratories, Inc.
Toxicology · 44d
Cleared Sep 29, 1983
AMES TDA KANAMYCIN TEST-CONTROL SERUM
K832769 · KJI
Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 29, 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775 · LCP
Abbott Laboratories
Chemistry · 44d
Cleared Sep 29, 1983
AFTER LOADING BUCHLER
K832789 · JAQ
Ellis Pharmaceutical Consulting, Inc.
Radiology · 45d
Cleared Sep 29, 1983
AMES TDA SISOMICIN TEST-CONTROL SERUM
K832792 · DJB
Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 29, 1983
MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY
K832797 · DLF
Syva Co.
Toxicology · 42d
Cleared Sep 29, 1983
AUTOMATIC TANGENT SCREEN 50
K832800 · HOO
CooperVision, Inc.
Ophthalmic · 42d
Cleared Sep 29, 1983
CORONARY ANASTOMOSIS MARKING SYSTEM
K832806 · DSY
Biotrac Laboratories
Cardiovascular · 42d
Cleared Sep 29, 1983
HARD CONTACT LENS CLEANER
K832810 · HPX
Blairex Laboratories, Inc.
Ophthalmic · 42d
Cleared Sep 29, 1983
CONCISE 2 SMALL PARTICLE LIGHT CURVED
K832834 · EBD
3M Company
Dental · 41d
Cleared Sep 29, 1983
DULBECCOS PHOSPHATE BUFFERED SALINE
K832835 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Sep 29, 1983
BASAL MED. #B9763 W/HANKS SALTS W/L-G
K832836 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Sep 29, 1983
NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM
K832841 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Sep 29, 1983
DULBECCOS MODIFIED EAGLES MEDIUM D5648
K832842 · KIT
Sigma Chemical Co.
Chemistry · 41d
Cleared Sep 29, 1983
RUBY KNIVES FOR OPHTH. SURGERY
K832844 · HNN
Keeler Instruments, Inc.
Ophthalmic · 38d
Cleared Sep 29, 1983
BLAISE-RATHAEL VOICE PROSTHESIS
K832852 · EWL
Richards Medical Co., Inc.
Ear, Nose, Throat · 44d
Cleared Sep 29, 1983
TPE DIAMOND POINTS
K832855 · DZP
Shofu Dental Corp.
Dental · 37d
Cleared Sep 29, 1983
INTRADISCAL THERAPY TRAY
K832858 · FMI
Ulti-Med Intl., Inc.
General Hospital · 37d
Cleared Sep 29, 1983
FLEX BUBBLE TUBING
K832865 · BYY
Sheridan Catheter Corp.
General Hospital · 37d