510(k) Device Clearances

HydroMARK Plus Breast Biopsy Site Marker

Devicor Medical Products, Inc.

Alkaline Phosphatase

Abbott Laboratories Diagnostics Division

Reusable 3 Button Fingerswitch Wand

Soniquence, LLC

Helio Kids; Apex P

Motion Composites

TMC Compression Implant System

Treace Medical Concepts

The Micro Screw System, Micro Screw System Basic

Hager& Meisinger GmbH

Harvest Printable Resin

Harvest Dental Products, LLC

Aventus Thrombectomy System

Inquis Medical

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL

Thermo Fisher Scientific

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

Gentuity, LLC

Revolution Peripheral Atherectomy System

Rex Medical, L.P.

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens

Innova Vision, Inc.

Maestro Platform

Moon Surgical

Elecsys Anti-HBc IgM

Roche Diagnostics

V-Laser

Wontech Co., Ltd.

Apollo Quattro (APQ-10M)

Weero Co., Ltd.

reVive Light Therapy Essentials

Led Technologies, Inc.

LightStim Elipsa

Led Intellectual Properties, LLC

Dexcom G7 Continuous Glucose Monitoring System

Dexcom, Inc.

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

Bonebridge AG

Luminopia One

Luminopia, Inc.

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

Shenzhen Hingmed Medical Instrument Co., Ltd.

MediOMx

Pmx, Inc.

Suction Irrigation Tubing Set

Advamedix, GmbH

Extraction Basket

Micro-Tech (Nanjing) Co., Ltd.

InnoVoyce VYLO

Innovoyce

ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-

Jiangsu Jiyuan Medical Technology Co., Ltd.

Arthrex Virtual Implant Positioning (VIP) System

Arthrex, Inc.

GIQuant

Motilent, Ltd.

ARIX Cannulated Screw System

Jeil Medical Corporation