510(k) Device Clearances

BPS Wrist Fracture System

Orthonovis, Inc.

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

MacroLux Medical Technology Co., Ltd.

Perifit Pump

X6 Innovations

TRIGEN META-NAIL Nail System

Smith & Nephew, Inc.

Sentinel Camera

Ai Optics

Venera 608 Deep Vein Thrombosis (DVT) Prevention System

Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

UniPrime A, UniPrime E, UniPrime E/C

S&C Polymer Silicon- Und Composite Spezialitäten GmbH

VX1+

Volta Medical

Stable-L Standalone Lumbar Interbody System

Nexus Spine, LLC

Patient Specific Planning Solution™ 3D Bone Models

Biomet Manufacturing Corp

Clear Aligner

Wuxi EA Medical Instruments Technologies Limited.

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

Smith & Nephew Medical, Ltd.

Clearblue® Early Detection Pregnancy Test

Spd Swiss Precision Diagnostics GmbH

Quantra Hemostasis Analyzer

Hemosonics, LLC

ProZip Knotless Implant

Riverpoint Medical

Persona™ Personalized Knee System

Zimmer, Inc.

Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)

Coloplast Corp.

ORA Method LED Gua Sha (GS-04)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

BD Alaris Pump Infusion Set

Carefusion (Bd)

AIRO Suction Unit (AIRO-01)

Cro, LLC

Disposable Laryngeal Electrodes

Suzhou Haishen Medical Device Associates Co., Ltd.

VariFuse Adjustable Infusion Catheter

Argon Medical Devices, Inc.

SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

Life Spine, Inc.

CAD - Lower GI (EC07-01)

Xiamen Inno Medical Technology Co., Ltd.

Sleep Apnea Feature

Samsung Electronics Co., Ltd.

Celox Rapid X-Ray Gauze

Medtrade Products , Ltd.

Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius

Shantou Institute of Ultrasonic Instruments Co., Ltd.

CreoDent Solidex Customized Abutment and Screw

Creodent Prosthetics, Ltd.

BosCATH Support Catheter

Sonorous NV, Inc.

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Jiangsu Zhiyu Medical Instrument Co, Ltd.