510(k) Device Clearances

Electronic Blood Pressure Monitor

Zhuhai Yueja Medical Device Technology Co., Ltd.

HESTIA

Genoray Co., Ltd.

Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

Thermo Fisher Scientific (Oxoid Ltd.)

Scenaria View 4.2

FUJIFILM Healthcare Americas Corporation

Elastic Impression Material

Beijing Okvd Biological Technology , Ltd.

SD TL Implant System

Arum Dentistry Co., Ltd.

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurg

Olympus Medical Systems Corporation

Diode laser Treatment System (K18)

Hebei Keylaser Sci-Tech Co.,Ltd

QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)

QT Medical, Inc.

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

Hefei Chimed Intelligent Machine Co., Ltd.

Signature Osteosynthesis Plate System

Signature Orthopaedic Pty , Ltd.

NPseal

Guard Medical, Inc.

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

Effortless Oxygen, LLC

VOLT™ Proximal Humerus 3.5 Plating System

Synthes GmbH

PNK Total Knee System

Tjc Life Co., Ltd.

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

DiaSorin, Inc.

Esperance pHLO Aspiration System

Phenox, Ltd.

Paradigm System

Proprio, Inc.

LacertaMatrix

Lacerta Life Sciences

Sapphire X3 Anterior Cervical Plate System

Spinal Elements, Inc.

NObreath®

Bedfont Scientific, Ltd.

EnDrive (EnDriveUS)

Advanced Technology Research (A.T.R.) S.R.L.

XT Stain/Glaze

Shenzhen Xiangtong Co., Ltd.

Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers

Boston Scientific Corporation

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439

Hunan Guangye Biotechnology Co., Ltd.

OMNIgene GUT Dx

DNA Genotek, Inc.

Oxygen concentrator

Zhengzhou Olive Electronic Technology Co., Ltd.

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

Medtronic, Inc.

ELISIO™-HX

Nipro Medical Corporation

Aveir Retrieval Catheter

ABBOTT MEDICAL