510(k) Device Clearances

RODIN Palette Naturalizing Kit

Belport Company, Inc., Gingi-Pak

Enhanced AURORA™ Medical Diode System, and related accessories

Psoria-Shield, Inc.

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H

Hunan Vathin Medical Instrument Co., Ltd.

CoaguChek XS Plus System

Roche Diagnostics

Arthrx Fracture Plates

Arthrex, Inc.

Lymphedema Compression

Jkh Health Co., Ltd.

t:slim X2 Insulin Pump with Interoperable Technology

Tandem Diabetes Care, Inc.

AS Software Version Asera

AS Software, LLC

AdvaTx

Advalight Aps

Medical Thulium Fiber Laser Systems (UroFiber 150Q)

Rhein Laser Technologies Co., Ltd.

AK 98 Dialysis Machine (955607)

Vantive US Healthcare, LLC

CurvaFix Low Profile System

Curvafix, Inc.

Ceevra Reveal 3

Ceevra, Inc.

SelectSite C304 Deflectable Catheter System, C315 Delivery System

Medtronic

BreatheSuite MDI V1

Breathesuite, Inc.

DenQ Sub SLA Implant System

Denq

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

Medimaging Integrated Solution, Inc (Miis)

CogNet QmTRIAGE

Medcognetics, Inc.

Symmetrix™ L Spinal System

Medtronic Sofamor Danek USA, Inc.

V-Laser

Wontech Co., Ltd.

EsoCheck Cell Collection Device

Lucid Diagnostics, Inc.

Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)

Intuitive Surgical, Inc.

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Topzir Biotech Co., Ltd.

BD Nano 2nd Gen Pen Needle

Becton, Dickinson and Company

CARPL (CARPL)

Carpl Ai, Inc.

BruxZir™ TintEFX Coloring Liquid

Prismatik Dentalcraft, Inc.

Alexandrite and Nd:YAG Laser models CANLASE and TORLASE

Canadian Pioneer Medical Technology Corporation (Cpmt Laser)

NOMAD Pro 3

Dental Imaging Technologies Corporation

uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

ARTFX MEDICAL Cervical PEEK Cages

Artfx Medical