510(k) Device Clearances

BONTREE PLUS

Hudens Bio Co., Ltd.

SOMNUM (SOMNUM)

Honeynaps Co., Ltd.

Ascent Cardiorespiratory Diagnostic Software

Medical Graphics Corporation

BioCode Gastrointestinal Pathogen Panel (GPP)

Applied BioCode, Inc.

Ortho MI System

Osteonic Co., Ltd.

Extroducer Infusion Catheter System

SmartWise Sweden AB

InVision Precision LVEF (LVEF)

InVision Medical Technology Corporation

Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)

Taishan Weibang Medical Equipment Co., Ltd.

Dexcom G6 Continuous Glucose Monitoring (CGM) System

Dexcom, Inc.

FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

Fujifilm Corporation

EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)

MicroVention, Inc.

Bluezone Model RX-450 Air Purifier

Bluezone Products, Inc.

FieldFlex Steerable Sheath

CenterPoint Systems, LLC

Medical Face Mask

Wuxi Yushou Medical Appliances Co., Ltd.

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System

I-Sens, Inc.

Camber Spine Navigation System

Camber Spine Technologies

Intracavitary/Interstitial System

Varian Medical Systems

Access Cortisol

Beckman Coulter, Inc.

Meniscus Versaflex

GM Dos Reis Industria e Comercio Ltda.

Liverty™ TIPS Access Set

Bard Peripheral Vascular, Inc.

NextAR™ TKA Platform My Knee PPS

Medacta International S.A.

Whitsundays Mask System

Resmed Pty Ltd (Registration Number: 3004604967)

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

Durio Ppe Sdn Bhd

imani i2Plus Breast Pump

Imani Co.

OCS Lung Donor Flush Set

TransMedics, Inc.

FUJIFILM Ultrasonic Endoscope EB-710US

Fujifilm Corporation

easy Claire

Y & J Bio Co., Ltd.

Avitus® Precision Autograft Delivery System

Avitus Orthopaedics, Inc.

Hexanium PLIF

Spinevision, S.A.S.

ARK Hydrocodone Assay

Ark Diagnostics, Inc.