510(k) Device Clearances

DentalMonitoring

Dental Monitoring Sas

Horos MD™

Icat Solutions, Ltd.

Bunkerhill Contrast CAC

BunkerHill Health

VitruvianScan (v1.0)

Perspectum, Ltd.

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axo

Axogen Corporation

Access OV Monitor

Beckman Coulter, Inc.

TightRail Guardian Motorized Dilator Sheath

Spectranetics, Inc.

SleepRight Snore Aid

Splintek, Inc.

LED Eye Perfector, model: EY-36A, EY-36B

Light Tree Ventures Europe B.V.

Annex® 2 Adjacent Level System

Spine Wave, Inc.

Vitesse (5.0)

Varian Medical Systems

Visant Medical Canalicular Plug

Visant Medical, Inc.

Interson USB Ultrasound System

Interson Corporation

Branchor Balloon Guide Catheter

Asahi Intecc Co., Ltd.

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Barrigel Injectable Gel

Palette Life Sciences

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

Light Tree Ventures Europe B.V.

FloPatch FP120

Flosonics Medical

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

Adaptiiv

Auto Folding Scooter, S21F

Heartway Medical Products Co., Ltd.

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

Canon Medical Systems Corporation

CARTO 3 EP Navigation System Version 7.2

Biosense Webster, Inc.

Light-curing Coloring Materials (ALCM)

Aidite (Qinhuangdao) Technology Co., Ltd.

ViewMateTM Ultrasound System

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Arc Adjustable Radial Cuff Compression Device

Tz Medical, Inc.

Power wheelchair (N6101)

Zhejiang Zhonglei Medical Technology Co. , Ltd.

Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-

Hologic, Inc.

Instylla Delivery Kit

Instylla, Inc.

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories

GE Healthcare Finland Oy

PressON Spinal Fixation System

Nexus Spine, LLC