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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
44377–44400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2012
SYNTHES USS CONNECTOR
K120571 · NKB
Synthes Spine
Orthopedic · 77d
Cleared May 14, 2012
LATEX EXAMINATION GLOVES (POWDER FREE)
K120692 · LYY
Top Calibre Sdn Bhd
General Hospital · 68d
Cleared May 14, 2012
SR PHONARES II
K120736 · ELM
Ivoclar Vivadent, AG
Dental · 66d
Cleared May 14, 2012
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
K120798 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 60d
Cleared May 13, 2012
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
K121127 · GEX
Cynosure, Inc.
General & Plastic Surgery · 30d
Cleared May 11, 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511 · KNT
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 255d
Cleared May 11, 2012
TATTOOSTAR EFFECT Y
K112669 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 240d
Cleared May 11, 2012
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
K113333 · BTR
Kimberly Clark Corporation
Anesthesiology · 179d
Cleared May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
K120057 · HLI
Bioptigen, Inc.
Ophthalmic · 123d
Cleared May 11, 2012
SUNMED GUIDE WIRE
K120119 · DQX
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 115d
Cleared May 11, 2012
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
K120183 · NBW
Broadmaster Biotech Corperation
Chemistry · 109d
Cleared May 11, 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND...
K120185 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 109d
Cleared May 11, 2012
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
K120249 · HIS
Church & Dwight Virginia Co., Inc.
Obstetrics & Gynecology · 105d
Cleared May 11, 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
K120296 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 101d
Cleared May 11, 2012
HEALIX ADVANCE PEEK ANCHOR
K120449 · HWC
Depuy Mitek
Orthopedic · 87d
Cleared May 11, 2012
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
K120821 · OCT
Misder, LLC
Gastroenterology & Urology · 53d
Cleared May 10, 2012
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK...
K112158 · LPH
Lima Corporate S.P.A.
Orthopedic · 288d
Cleared May 10, 2012
POCKETCPR
K112660 · LIX
Zoll Medical Corp
Cardiovascular · 240d
Cleared May 10, 2012
EOS SMALL BONE FIXATION SYSTEM
K112794 · HRS
TriMed, Inc.
Orthopedic · 227d
Cleared May 10, 2012
LUCINA-MELODI
K112856 · HGX
Genadyne Biotechnologies, Inc.
Obstetrics & Gynecology · 223d
Cleared May 10, 2012
ARRW EVOLUTION
K112896 · LJS
Arrow International (Subsidiary of...
General Hospital · 223d
Cleared May 10, 2012
ILWAIT TIMER OCULOPRESSOR
K112952 · LCC
Oryx Medical Pty, Ltd.
Ophthalmic · 218d
Cleared May 10, 2012
COMPLETE D 25-OH VITAMIN D CONTROL
K113177 · JJX
Quantimetrix Corp.
Chemistry · 195d
Cleared May 10, 2012
SENTRYSUITE PRODUCT LINE
K113813 · BTY
Carefusion Germany 234 GmbH
Anesthesiology · 139d