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
45049–45072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 29, 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293 · MAX
Spineology, Inc.
Orthopedic · 29d
Cleared Feb 28, 2012
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
K111456 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 279d
Cleared Feb 28, 2012
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · LON
bioMerieux, Inc.
Microbiology · 238d
Cleared Feb 28, 2012
E-PASS
K113148 · DTL
Synexmed(Shenzhen)Company Limited
Cardiovascular · 127d
Cleared Feb 28, 2012
TISSUE MARKER
K113202 · NEU
Focal Therapeutics
General & Plastic Surgery · 120d
Cleared Feb 28, 2012
NEON SYSTEM
K113346 · KWP
Ulrich GmbH & Co. KG
Orthopedic · 106d
Cleared Feb 28, 2012
MECTALIF TRANSFORAMINAL
K120024 · MAX
Medacta International S.A.
Orthopedic · 56d
Cleared Feb 28, 2012
MOSAIQ ONCOLOGY INFORMATION SYSTEM
K120067 · IYE
Impac Medical Systems, Inc.
Radiology · 50d
Cleared Feb 28, 2012
TOSHIBA 1.5T CARDIAC COIL
K120290 · MOS
Quality Electrodynamics
Radiology · 28d
Cleared Feb 27, 2012
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
K103824 · CFN
The Binding Site
Immunology · 424d
Cleared Feb 27, 2012
BARF BAND
K110821 · MVV
Doodlebug Products, LLC
Neurology · 340d
Cleared Feb 27, 2012
X-RAY VVA
K112807 · LLZ
Medis Medical Imaging Systems BV
Radiology · 153d
Cleared Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
K113007 · JQP
Bionime Corporation
Chemistry · 143d
Cleared Feb 27, 2012
WARP10,WARP75
K113231 · ILY
Quantum Devices, Inc.
Physical Medicine · 117d
Cleared Feb 27, 2012
COMPRESSIBLE LIMB THERAPY SYSTEM
K113275 · IRP
Wonjin Mulsan Co., Ltd.
Physical Medicine · 115d
Cleared Feb 27, 2012
CATALYST
K113276 · IYE
C-Rad Positioning AB
Radiology · 112d
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482 · JWH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Feb 27, 2012
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL...
K113545 · GEI
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 88d
Cleared Feb 27, 2012
RADIFORCE RX240
K113844 · LLZ
Eizo Nanao Corporation
Radiology · 61d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112690 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112691 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 24, 2012
SOL-M EXCHANGEABLE NEEDLES
K112777 · FMI
Sol-Milennium Medical, Inc.
General Hospital · 151d
Cleared Feb 24, 2012
SITESCRUB IPA DEVICE
K112791 · LKB
C. R. Bard
General Hospital · 151d
Cleared Feb 24, 2012
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
K112861 · KWQ
Sintea Plustek, LLC
Orthopedic · 147d