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
Vinyl Glove
Jiangsu Dihong Industry and Trade Co., Ltd.
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
Supersonic Imagine
True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
Vivid E80, Vivid E90, Vivid E95
Ge Medical Systems Ultrasound And
Reform Pedicle Screw System
Precision Spine, Inc.
0.55T 12Ch Breast Coil
Neocoil, LLC
Disposable Nitrile Examination Gloves
Foshan Kangkang Biotechnology Co., Ltd.
Female Culture Device; Male Culture Device; Transfer Device; Access Device
Zhejiang Kindly Medical Device Co., Ltd.
EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ
Samsung Medison Co., Ltd.
Neurophet SCALE PET
Neurophet., Inc.
Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
Changsha Anxiang Medical Technology Co., Ltd.
AETOS Shoulder System Stemless Humeral Prosthesis
Smith & Nephew, Inc.
ELAZ Nitrile Powder Free Examination Glove
Protect Gloves Co., Ltd.
Activmotion S DTO
Newclip Technics
MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc.
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, R
Stryker Corporation
Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
Fujifilm Corporation
Giraffe Omnibed Carestation CS1
Datex Ohmeda, Inc.
World Liner
Signature Orthopaedics Pty, Ltd.
BioFire COVID-19 Test 2
Biofire Defense, LLC
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Bausch & Lomb, Incorporated
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
Varian Medical Systems, Inc.
Oxygen Concentrator (J5A)
Foshan Kycare Medical Equipment Co., Ltd.
SMARxT Tubing and Connectors
LivaNova USA, Inc.
ON3D
3D Ons, Inc.
Enzyme Packed Cartridge - RELiZORB
Alcresta Therapeutics, Inc.
Lucent® XP
Spinal Elements
TearCare System
Sight Sciences, Inc.
UltiCare Disposable Pen Needles
Ultimed Incorporated
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