510(k) Device Clearances

Walking rehabilitation training electric wheelchair (ZW518)

Shenzhen Zuowei Technology Co., Ltd.

Disposable Syringe with Needle

Shandong Qinkai Medical Industry Co., Ltd.

Luminoah FLOW™ Enteral Nutrition System

Luminoah

Flash Ultrasound System 5100 Point of Care

Philips Ultrasound, LLC

Fenom Pro

Caire Diagnostics, Inc.

Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202);

Shenzhen Xinyan Medical Technology Co.,ltd.

ATEC IOM Accessory Instruments

Alphatec Spine, Inc.

Smart Wireless Stethoscope

Shanghai Hulu Devices Co., Ltd.

UltraEZ

Ultradent Products, Inc.

Southern Implants Instrument Trays

Southern Implants (Pty), Ltd.

da Vinci Surgical System (IS5000)

Intuitive Surgical, Inc.

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

bioMerieux, Inc.

Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Flo

C.R. Bard, Inc.

NobelZygoma PureSet™ Tray

Nobel Biocare Services AG

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

Dongguan Boyuan Intelligent Technology Co.,Ltd

Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (Th

Gbs Commonwealth Co., Ltd.

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

Impact PEEK Union Nail System

Nvision Biomedical Technologies

TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

Chongqing Rob Linka Science and Technology Co., Ltd.

AuroLase® System

Nanospectra Biosciences, Inc.

CVAC Aspiration System

Calyxo, Inc.

Second Opinion® Panoramic

Pearl, Inc.

ExcelsiusFlex™

Globus Medical, Inc.

Spin Care Disposable Protective Mask Level 3

Spintech, LLC

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

Topcon Corporation

ARTIS genio floor; ARTIS icono.explore floor

Siemens Medical Solutions USA, Inc.

Disposable Distal Attachment D-201 Series

Olympus Medical Systems Corp.

exoplan

Exocad GmbH

Wearable Breast Pump,Model S18

Ningbo Dearevery Electronic Technology Co., Ltd.

Ahmed® Glaucoma Valve Model FP8

New World Medical, Inc.