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
65137–65160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2005
BIOBLANKET SURGICAL MESH
K043259 · FTM
Kensey Nash Corp.
General & Plastic Surgery · 264d
Cleared Aug 15, 2005
U2 ACETABULAR COMPONENT
K050262 · LWJ
United Orthopedic Corp.
Orthopedic · 192d
Cleared Aug 15, 2005
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
K050320 · ITX
Ascendia Medtech AB
Radiology · 187d
Cleared Aug 15, 2005
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
K050575 · MDM
Futumeds Sdn Bhd
General & Plastic Surgery · 161d
Cleared Aug 15, 2005
ECLIPSE NEUROLOGICAL WORKSTATION
K050798 · GWF
Axon Systems, Inc.
Neurology · 139d
Cleared Aug 15, 2005
VCS S3T
K051131 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 104d
Cleared Aug 15, 2005
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · IOR
Medline Industries, Inc.
Physical Medicine · 88d
Cleared Aug 15, 2005
HABIB 4X
K051420 · GEI
Emcision , Ltd.
General & Plastic Surgery · 75d
Cleared Aug 15, 2005
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT...
K051613 · ODA
Olympus Medical Systems Corporation
Gastroenterology & Urology · 59d
Cleared Aug 15, 2005
STERLING CANCELLOUS CHIPS
K051615 · MQV
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Aug 15, 2005
OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR
K051700 · GAM
Medchannel, LLC
General & Plastic Surgery · 52d
Cleared Aug 15, 2005
HIPPOCAMPE WHEELCHAIR
K051709 · IQC
Vipamat Technologie
Physical Medicine · 49d
Cleared Aug 15, 2005
MELIDE FIBEROPTIC LIGHT
K051786 · FST
Designs For Vision, Inc.
General & Plastic Surgery · 45d
Cleared Aug 15, 2005
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA...
K051809 · LLZ
Medical Insight A/S
Radiology · 41d
Cleared Aug 15, 2005
ULTRAPACS
K051813 · LLZ
Ultrarad Corporation
Radiology · 41d
Cleared Aug 15, 2005
C CHANGE SOLUTION WARMER
K051819 · LHC
C Change Surgical, LLC
General Hospital · 41d
Cleared Aug 15, 2005
ENSITE VERISMO SOFTWARE
K051840 · LLZ
St Jude Medical
Radiology · 39d
Cleared Aug 15, 2005
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 15, 2005
VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
K052130 · EIH
Vident
Dental · 10d
Cleared Aug 12, 2005
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY
K043260 · MTJ
Orthocon, LLC
General & Plastic Surgery · 261d
Cleared Aug 12, 2005
BIOGEL LATEX STERILE POWDER-FREE GLOVE
K050899 · KGO
Regent Medical Americas, LLC
General Hospital · 123d
Cleared Aug 12, 2005
506 PATIENT MONITOR
K051038 · DRT
Ciriticare Systems, Inc.
Cardiovascular · 109d
Cleared Aug 12, 2005
DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051129 · LPL
Innova Vision, Inc.
Ophthalmic · 101d
Cleared Aug 12, 2005
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121,...
K051370 · JOL
Baxter Healthcare Corp
General Hospital · 78d