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
ProCinch, QuadCinch
Riverpoint Medical
BD Flu+ Syringe
Becton, Dickinson and Company
Mecun SpO2 sensor
Shenzhen Mecun Medical Supply Co., Ltd.
Videa Caries Assist
Videahealth, Inc.
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-61
Olympus Medical Systems Corp.
Manual Wheelchair (HM305-Air1, HM305-Air2)
Suzhou Master Machinery Manufacturing Co.,Ltd
coactiv+ Antimicrobial Wound Gel
Kane Biotech, Inc.
SpotLight/SpotLight Duo (with DLIR option)
Arineta , Ltd.
Powder Free Nitrile Examination Gloves, Orange
Shanxi Hongjin Plastic Technology Co., Ltd.
Disposable Enteral Feeding Sets
Beijing L&Z Medical Technology Development Co., Ltd.
Biocore9 Acetabular Cup System
Biocore9, LLC
AIR OPTIX COLORS
Alcon Laboratories, Inc.
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
Actuated Medical, Inc.
MYAH
Visia Imaging S.R.L.
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
Sangi Co., Ltd.
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Sysmex America, Inc.
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Insulet Corporation
GCI Sterilization Wrappers
George Courey, Inc.
Tempus ECG-Low EF
Tempus AI, Inc.
Videa Dental AI
Videahealth, Inc.
Arthrex Compression FT Pins
Arthrex, Inc.
MediOMx
Pmx, Inc.
Platform treatment system
Shanghai Apolo Medical Technology Co., Ltd.
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 1
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Magnus Medical, Inc.
Spectrum Saliva Collection Device
Spectrum Solutions, LLC
Magnetic Surgical System
Levita Magnetics International Corp
Senhance Surgical System
Asensus Surgical, Inc.
Voyant® Open Fusion Device (EB240/Open Fusion)
Applied Medical Resources Corp.
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Merit Medical Ireland, Ltd.
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