510(k) Device Clearances

Surgical Gown

Wujiang Tutaike Textiles & Finishing Co., Ltd.

SkyOPS™ Orthopedic Plate System

Sky Surgical, LLC

uOmniscan

Shanghai United Imaging Healthcare Co., Ltd.

Ziehm Solo FD

Ziehm Imaging GmbH

Dental Handpiece, Model CA160, CA160L, and CA500L

Micro-Nx Co., Ltd.

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

Shenzhen Finicare Co., Ltd.

TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems

ZheJiang Decans Medical Devices Co., Ltd.

AHI System

Fifth Eye, Inc.

Conductive Silicone Rubber Electrode

Guangzhou Xinbo Electronic Co., Ltd.

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Makani Science™ Respiration Monitoring System

Makani Science, Inc.

iFuse TORQ® Implant System

SI-BONE, Inc.

Joule diVa System

Sciton, Inc

EzRay Air 2 Wall (Model: VEX-S350W)

VATECH Co., Ltd.

Ochsner Connected Inhaler Sensor

Ochsner Clinic Foundation

ClariPulmo

Claripi, Inc.

KLS Martin Pure Pectus System

KLS Martin L.P.

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd.

Synapse 3D Base Tools v6.6

Fujifilm Corporation

UroLift System Rigid Retrieval Kit Sterilization Tray

Neotract, Inc.

Electric Scooter (FDB08, FDB08A, FDB12)

Anhui JBH Medical Apparatus Co., Ltd.

i-STAT CG4+ cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

Renuvion Dermal Handpiece, Renuvion Dermal System

Apyx Medical Corporation (Formerly Bovie Medical Corporation

Gemini Cervical Fusion Cage System

ZheJiang Decans Medical Devices Co., Ltd.

Ki Power Tilt System

Ki Mobility, LLC

Excelsior System

Blue Ocean Global

PreOp v3

Clouds of Care

Disposable Insulin Pen Needle

Ningbo Medsun Medical Co., Ltd.

EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)

Ewoosoft Co., Ltd.

ARTFX Trauma Bone Plate and Screw System

Artfx Medical