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
34297–34320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2015
Conventus PRS System
K151379 · HRS
Conventus Orthopaedics, Inc.
Orthopedic · 83d
Cleared Aug 13, 2015
syngo.via RT Image Suite
K151380 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Aug 13, 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448 · LPH
Zimmer, Inc.
Orthopedic · 76d
Cleared Aug 13, 2015
Respiratory Gating for Scanners
K151533 · JAK
Varian Medical Systems, Inc.
Radiology · 66d
Cleared Aug 13, 2015
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K151642 · JXM
Healgen Scientific, LLC
Chemistry · 56d
Cleared Aug 13, 2015
Reusable Full Silicone Cover
K151702 · LIX
Laerdal Medical AS
Cardiovascular · 50d
Cleared Aug 13, 2015
Arc Endocuff Vision
K151801 · FED
Boddingtons Plastics, Ltd.
Gastroenterology & Urology · 42d
Cleared Aug 13, 2015
Turnpike catheter
K151981 · DQY
Vascular Solution, Inc.
Cardiovascular · 27d
Cleared Aug 12, 2015
Spaulding Electrocardiograph 2100iQ
K150564 · DPS
Spaulding Clinical Research, LLC
Cardiovascular · 159d
Cleared Aug 12, 2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System,...
K151064 · OVE
Biomet Spine
Orthopedic · 114d
Cleared Aug 12, 2015
Arthrex BioSync® Bone Wedge
K151256 · PLF
Arthex, Inc.
Orthopedic · 92d
Cleared Aug 12, 2015
RECON system
K151407 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 78d
Cleared Aug 12, 2015
SI-TECHNOLOGY® SI-DESIS® SCREWS
K151462 · OUR
Si-Technology, LLC
Orthopedic · 72d
Cleared Aug 12, 2015
RS80A Diagnostic Ultrasound System
K151663 · IYN
Samsung Medison Co., Ltd.
Radiology · 54d
Cleared Aug 12, 2015
Central Venous Pressure System
K151776 · PFA
Mespere Lifesciences, Inc.
Cardiovascular · 42d
Cleared Aug 12, 2015
Synapse Cardiovascular
K151859 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 35d
Cleared Aug 12, 2015
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
K151929 · OMB
Persyst Development Corporation
Neurology · 29d
Cleared Aug 12, 2015
Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935 · LYR
Alere San Diego, Incorporated
Microbiology · 29d
Cleared Aug 12, 2015
LightSheer Desire Light Laser System
K151947 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 28d
Cleared Aug 11, 2015
TM SAFETY NEEDLE
K142765 · FMI
Thinkmed Medical Technology Co., Ltd.
General Hospital · 320d
Cleared Aug 11, 2015
Disposable Pressure Manometer (DPM)
K143148 · CAP
Westmed, Inc.
Anesthesiology · 281d
Cleared Aug 11, 2015
Cathivex ¿GV filter units
K143583 · FPB
Merck Millipore , Ltd.
General Hospital · 236d
Cleared Aug 11, 2015
syngo.CT Single Source Dual Energy
K150745 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Aug 11, 2015
syngo.CT Dual Energy
K150757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 141d