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
67321–67344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2004
FLEXI-STAT SP02 EAR SENSOR
K042675 · DPZ
Elekon Industries U.S.A., Inc.
Anesthesiology · 68d
Cleared Dec 06, 2004
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY...
K042817 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 55d
Cleared Dec 06, 2004
ESTENIA C&B
K042929 · EBF
Kuraray Medical Kurashiki Plant
Dental · 45d
Cleared Dec 06, 2004
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
K043186 · DXN
Health & Life Co., Ltd.
Cardiovascular · 19d
Cleared Dec 06, 2004
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · MEA
Hospira, Inc.
General Hospital · 12d
Cleared Dec 03, 2004
ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER...
K041834 · MUH
Takara Belmont USA, Inc.
Radiology · 149d
Cleared Dec 03, 2004
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
K042148 · DQK
Ge Medical Syst. Information...
Cardiovascular · 116d
Cleared Dec 03, 2004
UNIMIDE
K042284 · GAR
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 101d
Cleared Dec 03, 2004
OLYMPUS LACTATE, OSR6193
K042406 · JIT
Olympus America, Inc.
Chemistry · 91d
Cleared Dec 03, 2004
GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042427 · LNS
Genemed, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 03, 2004
CERASYS - ZR
K042548 · EIH
Cerasys, Inc.
Dental · 74d
Cleared Dec 03, 2004
SHIMADZU COLLIMATOR R-20J
K042840 · IZX
Shimadzu Corp.
Radiology · 50d
Cleared Dec 03, 2004
CONTOUR FOREHEAD/BROWLIFT THREAD
K042856 · GAW
Surgical Specialties Corp
General & Plastic Surgery · 60d
Cleared Dec 03, 2004
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
K042858 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 03, 2004
CORRECT DENTAL IMPRESSION MATERIAL
K042860 · ELW
Handae Chemical Co., Ltd.
Dental · 49d
Cleared Dec 03, 2004
BD ONECATH
K042862 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 49d
Cleared Dec 03, 2004
HOVEROUND SE-3 POWERCHAIR
K042920 · ITI
Hoveround Corp.
Physical Medicine · 42d
Cleared Dec 03, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
K042967 · DXN
A&D Engineering, Inc.
Cardiovascular · 36d
Cleared Dec 03, 2004
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49,...
K043023 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 30d
Cleared Dec 03, 2004
HOVEROUND E100 POWER CHAIR
K043069 · ITI
Hoveround Corp.
Physical Medicine · 25d
Cleared Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · JOX
Medtronic Vascular
Hematology · 25d
Cleared Dec 02, 2004
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
K041693 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 163d
Cleared Dec 02, 2004
MODULAR ARTHRODESIS NAIL
K042409 · HSB
Biomet, Inc.
Orthopedic · 90d
Cleared Dec 02, 2004
COATEST SP FVIII
K042576 · GGP
Instrumentation Laboratory CO
Hematology · 71d