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
73705–73728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750 · MML
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jan 27, 2003
TERABYTE 2000 HAIR REMOVER
K022341 · GEX
Terabyte Co.
General & Plastic Surgery · 193d
Cleared Jan 27, 2003
ERA 3000
K022360 · DTA
Biotronik, Inc.
Cardiovascular · 192d
Cleared Jan 27, 2003
CELSIUS CONTROL SYSTEM
K022366 · NCX
Innercool Therapies
Neurology · 189d
Cleared Jan 27, 2003
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED,...
K022929 · MKJ
Cardiac Science, Inc.
Cardiovascular · 145d
Cleared Jan 27, 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · GEX
Candela Corp.
General & Plastic Surgery · 144d
Cleared Jan 27, 2003
SPEEDICATH
K023254 · GBM
Coloplast Corp.
Gastroenterology & Urology · 119d
Cleared Jan 27, 2003
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL:...
K023624 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jan 27, 2003
PALOMAR Q-YAG ND:YAG LASER SYSTEM
K023967 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Jan 27, 2003
VACUETTE TRACE ELEMENTS TUBES
K023971 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 59d
Cleared Jan 27, 2003
ACCURA ELITE SHUNT SYSTEM
K024040 · JXG
Phoenix Biomedical Corp.
Neurology · 52d
Cleared Jan 27, 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101 · JXG
Phoenix Biomedical Corp.
Neurology · 46d
Cleared Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jan 24, 2003
MUCOGRAFT
K012423 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 543d
Cleared Jan 24, 2003
GOOD LUBRICATIONS
K020586 · KMJ
Biofilm, Inc.
General Hospital · 336d
Cleared Jan 24, 2003
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K021547 · DSY
Jotec GmbH
Cardiovascular · 259d
Cleared Jan 24, 2003
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 214d
Cleared Jan 24, 2003
PEGASUS NASAL CPAP SYSTEM
K022192 · BZD
Sensor Medics Corp.
Anesthesiology · 203d
Cleared Jan 24, 2003
NEOGENESYS 2K
K022433 · LIH
Sanexas Intl. GmbH
Neurology · 183d
Cleared Jan 24, 2003
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
K022445 · HIH
Olympus Optical Co., Ltd.
Obstetrics & Gynecology · 183d
Cleared Jan 24, 2003
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
K022697 · ITI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 164d
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-L3
K023040 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 134d
Cleared Jan 24, 2003
EPW POWERED WHEELCHAIR, GP-201
K023148 · ITI
Emg Technology Co., Ltd.
Physical Medicine · 126d
Cleared Jan 24, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-M4
K023166 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 123d