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
59353–59376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2007
CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
K070288 · OCL
Medtronic Vascular
Cardiovascular · 139d
Cleared Jun 18, 2007
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A...
K071020 · MHX
Ge Healthcare
Cardiovascular · 69d
Cleared Jun 18, 2007
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010,...
K071125 · KRD
Aga Medical Corp.
Cardiovascular · 56d
Cleared Jun 15, 2007
APNEALINK
K070263 · MNR
Resmed Germany, Inc.
Anesthesiology · 140d
Cleared Jun 15, 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 100d
Cleared Jun 15, 2007
HYDROCOIL EMBOLIC SYSTEM (HES)
K070656 · HCG
MicroVention, Inc.
Neurology · 98d
Cleared Jun 15, 2007
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
K070869 · EFB
Dentalez, Inc.
Dental · 78d
Cleared Jun 15, 2007
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K070901 · GXN
Bioplate, Inc.
Neurology · 74d
Cleared Jun 15, 2007
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
K071387 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 28d
Cleared Jun 14, 2007
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876 · FEB
Medivators Reprocessing Systems
General Hospital · 167d
Cleared Jun 14, 2007
STOCKERT NEURO N50, MODEL12267
K070336 · GXD
Stockert GmbH
Neurology · 129d
Cleared Jun 14, 2007
AOS TIBIAL NAIL
K070444 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 119d
Cleared Jun 14, 2007
LUMILOC (TM) SAFETY INTRODUCER NEEDLE
K070449 · KNT
Specialized Health Products...
Gastroenterology & Urology · 119d
Cleared Jun 14, 2007
CANNULATED SCREW
K070617 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 101d
Cleared Jun 14, 2007
PROXENON 350, MODEL 902XX
K071218 · FST
Welch Allyn, Inc.
General & Plastic Surgery · 43d
Cleared Jun 13, 2007
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883 · BZQ
Gereonics, Inc.
Anesthesiology · 260d
Cleared Jun 13, 2007
STRIDE MICROCATHETER
K062885 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 260d
Cleared Jun 13, 2007
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS...
K070198 · GCJ
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 142d
Cleared Jun 13, 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · NBW
Nova Biomedical Corp.
Chemistry · 138d
Cleared Jun 13, 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 121d
Cleared Jun 13, 2007
NASOPHARYNGOSCOPE, BRONCHOSCOPE
K070580 · EOB
Xion GmbH
Ear, Nose, Throat · 104d
Cleared Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · DIC
Dade Behring, Inc.
Chemistry · 77d
Cleared Jun 13, 2007
LOWTOP PEDICLE SCREW SYSTEM
K070933 · MNH
Sanacor
Orthopedic · 71d
Cleared Jun 13, 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · LIT
Boston Scientific Corp
Cardiovascular · 62d