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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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