510(k) Device Clearances

EOlife®

Archeon

Neodent Implant System - Mini Abutment 60°

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Stellaris Elite vision enhancement system

Bausch and Lomb

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

Sebia

cvi42 Auto Imaging Software Application

Circle Cardiovascular Imaging, Inc.

Oxygen Concentrator (ZY-10AB/115)

Foshan Care Medical Technology Co., Ltd.

Active-V Total Knee System; World Total Knee System

Signature Orthopaedics Pty, Ltd.

Brainomix 360 e-CTA

Brainomix Limited

Zeta Cranial Navigation System

Zeta Surgical

PAPAYA & PAPAYA Plus

Genoray Co., Ltd.

BTI Interna 3.0 Dental Implant System UnicCa®

B.T.I. Biotechnology Institute, Sl.

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), Smart

STERIS Corporation

Nihon Kohden NKV-440 Ventilator System

Nihon Kohden Orangemed, Inc.

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

Orchid Safety Release Valve(TM)

Linear Health Sciences, LLC

Reflow System Mini and ReFlow Mini Flusher

Anuncia Medical, Inc.

LOSPA TKR System

Corentec Co., Ltd.

DISINTEK™ PA Test Strips

Serim Research

Endoform Reconstructive Template - PLGA

Aroa Biosurgery , Ltd.

SwissGraft X

Geistlich Pharma AG

The Alma Opus System, Colibri Applicator and Tips

Alma Lasers, Inc.

Neodent Implant System – Custom Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

CavaClear Laser Sheath

Spectranetics, Inc.

NxtGen Infant Transport Incubator

International Biomedical

CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0

MacroLux Medical Technology Co., Ltd.

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Alere NT-proBNP for Alinity i

Axis-Shield Diagnostics, Ltd.

SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

Thera B Medical Products

uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI

Shanghai United Imaging Healthcare Co., Ltd.

Vektor Computational ECG Mapping System (vMap®)

Vektor Medical, Inc.