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
45841–45864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · HSB
Synthes USA Products, LLC
Orthopedic · 146d
Cleared Nov 28, 2011
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K113153 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared Nov 28, 2011
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K113198 · DXT
Navilyst Medical, Inc.
Cardiovascular · 28d
Cleared Nov 28, 2011
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
K113241 · FMF
Becton Dickinson
General Hospital · 26d
Cleared Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636 · FPA
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Nov 25, 2011
LIGHT GUIDE CABLE
K111342 · HBI
Schott North America
General & Plastic Surgery · 196d
Cleared Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · GKZ
Siemens Healthcare Diagnostics
Hematology · 435d
Cleared Nov 23, 2011
INGENUITY TF PET/MR
K103483 · OUO
Philips Healthcare (Cleveland)
Radiology · 362d
Cleared Nov 23, 2011
HAMILTON-G5
K103803 · CBK
Hamilton Medical AG
Anesthesiology · 330d
Cleared Nov 23, 2011
VITALOGRAPH MODEL 7100 - VITALOJAK
K110525 · DSH
Vitalograph (Ireland) , Ltd.
Cardiovascular · 273d
Cleared Nov 23, 2011
ROM PLUS
K110605 · NQM
Clinical Innovations, LLC
Chemistry · 266d
Cleared Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS,...
K110619 · MRG
Biokit, S.A.
Chemistry · 265d
Cleared Nov 23, 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · ODP
Zimmer Spine, Inc.
Orthopedic · 216d
Cleared Nov 23, 2011
MAGNETOM AERA AND MAGNETOM SKYRA
K111242 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 204d
Cleared Nov 23, 2011
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A
K111748 · JOW
Joy Long
Cardiovascular · 154d
Cleared Nov 23, 2011
PROFEMUR GLADIATOR HA HIP STEM
K112150 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 119d
Cleared Nov 23, 2011
HOTDOG PATIENT WARMING SYSTEM
K112488 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 86d
Cleared Nov 23, 2011
QUIXIE NEBULIZER
K112564 · CAF
Odyssey Medical Technologies
Anesthesiology · 82d
Cleared Nov 23, 2011
SDX-4343CS
K112751 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 63d
Cleared Nov 23, 2011
PENUMBRA SYSTEM MAX
K113163 · NRY
Penumbra, Inc.
Neurology · 28d
Cleared Nov 23, 2011
CAROTID COIL GE 1.5T
K113280 · MOS
Tursiop Technologies, LLC
Radiology · 16d
Cleared Nov 22, 2011
SAFIRE
K103424 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 365d
Cleared Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 281d
Cleared Nov 22, 2011
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · DQA
Taidoc Technology Corporation
Anesthesiology · 237d