510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Dental Scaler and Air Polisher
Guilin Woodpecker Medical Instrument Co., Ltd.
V80 Anesthetic Vaporizer (V80)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Syngo Carbon Clinicals
Siemens Healthcare GmbH
mi-eye 3 needlescope with cannula, mi-tablet 3
Trice Medical, Inc.
Apex Flex
Sprintray, Inc.
NightOwl
Ectosense NV
LONGY Implant and LONGY-N Implant
Noris Medical , Ltd.
MARVEL Growing Rods
Globus Medical, Inc.
Galen ES Cooperative Surgical Assistant Platform, Galen ES
Galen Robotics
Powered Wheelchair (NXN20-205, NXN20-205M)
Zhejiang Nysin Medical Co., Ltd.
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentan
Gmp Medicare Sdn. Bhd.
NAJA Gastrointestinal Catheter
Chess Medical, Inc.
Zuno Smart Sterilization Container
Zuno Medical, Inc.
E1000 Dx Digital Pathology Solution
Shandon Diagnostics Limited
Blue Nitrile Exam Gloves
Jiangxi Surefine Medical Co., Ltd.
E3D-C Interbody System
Evolution Spine
Tomey Cornea/Anterior Segment OCT (CASIA2)
Tomey Corporation
Neuromuscular Transmission Monitor TOF3D (2510091)
MIPM Mammendorfer Institut für Physik und Medizin GmbH
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Ki
Access Vascular, Inc.
Inspire HCR and HCR DUAL cardiotomy reservoirs
Sorin Group Italia S.R.L.
Soteria.AI
Omega Medical Imaging, LLC
ST AIA-PACK BNP Assay
Tosoh Bioscience, Inc.
OsseoFit Stemless Shoulder System
Zimmer, Inc.
BD Texium Closed Male Luer
Care Fusion
InferCare RECIST
Beijing Infervision Healthcare Medical Technology Co., Ltd.
LED Facial Mask
Shenzhen Sunsred Technology Co.,Ltd
Disposable Medical Examination Nitrile Gloves
Raxwell Industrial, LLC
DreamClear
Somnomed Technologies Inc., Doing Business AS Remware
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Owen Mumford, Ltd.
LifeLens Wireless ECG Monitor
LifeLens Technologies, Inc.
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