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

Filters: Cleared only ×
175,820 results
42505–42528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2012
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K123564 · IYN
Ge Healthcare
Radiology · 28d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 18, 2012
TRAUS SIP10
K123695 · EKY
Saeshin Precision Co., Ltd.
Dental · 15d
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · MYA
Ventana Medical Systems, Inc.
Pathology · 719d
Cleared Dec 17, 2012
LACRIFAST
K120886 · OKS
Hiroyasu Higuchi
Ophthalmic · 269d
Cleared Dec 17, 2012
ALPHA CRYPTOCOCCAL ANTIGEN EIA
K120946 · MDU
Immuno-Mycologics, Inc.
Microbiology · 263d
Cleared Dec 17, 2012
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
K120955 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 262d
Cleared Dec 17, 2012
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
K122211 · HAW
Synthes Spine
Neurology · 145d
Cleared Dec 17, 2012
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509 · KWP
Vertiflex, Inc.
Orthopedic · 122d
Cleared Dec 14, 2012
ASCENDX VCF REDUCTION SYSTEM
K100404 · NDN
Aoi Medical, Inc.
Orthopedic · 1032d
Cleared Dec 14, 2012
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT...
K113018 · GEX
Beijing Syntech Laser Co., Ltd.
General & Plastic Surgery · 430d
Cleared Dec 14, 2012
MOLECULAR ADSORBENT RECIRCULATING(MARS)
K113313 · FLD
Gambro Renal Products, Inc.
Gastroenterology & Urology · 401d
Cleared Dec 14, 2012
GLIADIN IGA AND GLIADIN LGA
K113377 · MST
Grifols USA, LLC
Immunology · 394d
Cleared Dec 14, 2012
CONELOG IMPLANT SYSTEM
K113779 · DZE
Altatec GmbH
Dental · 358d
Cleared Dec 14, 2012
NDX ABUTMENTS
K121117 · NHA
National Dentex Corp
Dental · 246d
Cleared Dec 14, 2012
PERCUNAV
K121498 · JAK
Philips Health Care
Radiology · 207d
Cleared Dec 14, 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · KWQ
Corelink, LLC
Orthopedic · 206d
Cleared Dec 14, 2012
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · MNT
Respironics, Inc.
Anesthesiology · 196d
Cleared Dec 14, 2012
COUGHASSIST T70 DEVICE
K121955 · NHJ
Respironics, Inc.
Anesthesiology · 164d
Cleared Dec 14, 2012
OXTI INFLATION DEVICE
K122152 · MAV
Oxti Corporation
Cardiovascular · 147d
Cleared Dec 14, 2012
EMPOWER CLEAR
K122753 · NJM
American Orthodontics
Dental · 98d
Cleared Dec 14, 2012
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE...
K122827 · DTZ
Medtronic, Inc.
Cardiovascular · 91d
Cleared Dec 14, 2012
VIDEO SYSTEM CENTER
K122831 · NTN
Olympus Medical Systems Corp.
Gastroenterology & Urology · 88d
Cleared Dec 14, 2012
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
K122840 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 88d