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
31057–31080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 2016
Sterling 5W Diode Laser
K160413 · GEX
CAO Group, Inc.
General & Plastic Surgery · 218d
Cleared Sep 21, 2016
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T,...
K160816 · FLL
Nexmed Technology Co., Ltd.
General Hospital · 181d
Cleared Sep 21, 2016
Spinal fixation system
K161151 · MNH
Canwell Medical Co., Ltd.
Orthopedic · 149d
Cleared Sep 21, 2016
E-CUBE 11
K161439 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 120d
Cleared Sep 21, 2016
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K161591 · NKG
Globus Medical, Inc.
Orthopedic · 104d
Cleared Sep 21, 2016
ARIX Hand System
K161746 · HRS
Jeil Medical Corporation
Orthopedic · 89d
Cleared Sep 21, 2016
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
K161843 · IYN
Toshibamedical Systems Corporation
Radiology · 78d
Cleared Sep 21, 2016
Solitaire Platinum Revascularization Device
K161879 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 75d
Cleared Sep 21, 2016
Affinity NT Oxygenator with Cortiva BioActive Surface
K162016 · DTZ
Medtronic, Inc.
Cardiovascular · 62d
Cleared Sep 21, 2016
CAAS MRV
K162112 · LLZ
Pie Medical Imaging BV
Radiology · 54d
Cleared Sep 21, 2016
Cascadia Interbody System
K162264 · MAX
K2m, Inc.
Orthopedic · 41d
Cleared Sep 21, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K162338 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Sep 21, 2016
Scenium
K162339 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 21, 2016
UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge
K162345 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 21, 2016
Surefire Guiding Catheter
K162359 · DQY
Surefire Medical, Inc.
Cardiovascular · 29d
Cleared Sep 21, 2016
da Vinci Xi 12 – 8 mm Reducer
K162411 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared Sep 20, 2016
F&P Eson 2 Nasal Mask
K153505 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 288d
Cleared Sep 20, 2016
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · DRA
Hansen Medical, Inc.
Cardiovascular · 169d
Cleared Sep 20, 2016
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm),...
K161086 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 155d
Cleared Sep 20, 2016
GentleCath Glide Intermittent Catheter
K161344 · KOD
Convatec Limited
Gastroenterology & Urology · 130d
Cleared Sep 20, 2016
Catalys Precision Laser System
K161455 · OOE
Optimedica Corporation
Ophthalmic · 117d
Cleared Sep 20, 2016
Personal Kinetigraph (PKG) System
K161717 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 90d
Cleared Sep 20, 2016
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme...
K161721 · CDD
Diazyme Laboratories
Chemistry · 90d
Cleared Sep 20, 2016
PINPOINT Endoscopic Fluorescence Imaging System
K161792 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 82d