510(k) Device Clearances

Origin™

Nerv Technology Inc. (D.B.A.) Fluidai Medical

MetriCide™ OPA Plus Solution Test Strip

Steris

SleepRes PAP System

Sleepres, Inc.

Digital flat panel detector

Iray Technology Taicang , Ltd.

ROSA ONE Brain Application

Medtech S.A.S

IPL HAIR REMOVAL HANDSET, Model: IPL-666

Shenzhen Junbobeauty Technology Co., Ltd.

V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

MSKai

Mskai

Soteria E-View

Omega Medical Imaging, LLC

ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring

Longeviti Neuro Solutions

SURGIVISIO Device

Ecential Robotics

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

Seers Technology Co., Ltd.

Fetal Pillow

CooperSurgical, Inc.

Alere NT-proBNP for Alinity i Reagent Kit

Axis-Shield Diagnostics, Ltd.

Capsulo

Quantel Medical

VitruvianScan (v1.0)

Perspectum, Ltd.

BONHAWA Respiratory Humidifier

Telesair, Inc.

BioFire Joint Infection (JI) Panel

Biofire Diagnostics, LLC

EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS

DRTECH Corporation

T3 Platform software

Etiometry, Inc.

Zoom System (Zoom 4S Catheter)

Imperative Care, Inc.

SecurePortIV Advanced Catheter Securement Adhesive

Adhezion Biomedical, LLC

AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup

Hangzhou AllTest Biotech Co., Ltd.

Patriot Duo

Patriot Laser, LLC

SmartClip Secure Soft Tissue Marker

Elucent Medical, Inc.

WallFlex™ Biliary RX Stent System

Boston Scientific Corporation

Gepotidacin GEP 10 µg

Liofilchem, Inc.

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Bridge TO Life

Medical Surgical Mask

Azur Medical Company, Inc.

InVision™ 3T Recharge Operating Suite

Imris Imaging, Inc.