Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156337–156360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1983
HSI ELITE #EC CUSTOM CANAL HEAR-AID
K832701 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 29, 1983
SHILEY GAS FILTER
K832704 · KRI
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 29, 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726 · CDD
Diagnostic Products Corp.
Immunology · 48d
Cleared Sep 29, 1983
RADIOTHERAPY MGMT. SYSTEM RMS-1000
K832732 · IYE
Varian Assoc., Inc.
Radiology · 55d
Cleared Sep 29, 1983
XEROX 120 SYS MAMMOGRAPHIC X-RAY
K832733 · IZH
Xerox Medical Systems
Radiology · 41d
Cleared Sep 29, 1983
KEMTEK 103 RIA GAMMA COUNTER
K832735 · JJJ
Kemble Instruments, Inc.
Chemistry · 56d
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