510(k) Device Clearances

Sleepiz One+ (2.5)

Sleepiz AG

TACTIX Vector Syndesmosis System

Vilex, LLC

Nanox.ARC X

Nano-X Imaging , Ltd.

VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Ma

Acist Medical Systems, Inc.

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/

Thermo Fisher Scientific

Osteotomy Truss System (OTS)

4Web Medical, Inc.

PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PIC

Smith Nephew Medical Limited

N2

Megagen Implant Co., Ltd.

NextGen Pedicle Screw System

Corelink, LLC

Radialis PET Camera

Radialis, Inc.

Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)

Stryker Sustainability Solutions

Clarify DL

Ge Medical Systems Israel, Functional Imaging

Helio Kids; Apex P

Motion Composites

ABL90 FLEX PLUS System

Radiometer Medicals Aps

True Definition DL

Ge Healthcare Japan Corporation

Telepack +

Karl Storz Endoscopy America, Inc.

NOABLE LASER

Daeju Meditech Engineering Co., Ltd.

Sonosite LX Ultrasound System

FUJIFILM Sonosite, Inc.

NovaGuide 2 Intelligent Ultrasound

Novasignal Corporation

Inomax DSIR

Mallinckrodt Manufacturing, LLC

Plasma Shield

Plasmatica, Ltd.

BD Alaris™ Pump Infusion Sets

Care Fusion

RealNow

Yiwei Medical Technology Co., Ltd.

Disposable Nitrile Examination Glove

Jiangsu Cureguard Glove Co., Ltd.

SD TL Implant System

Arum Dentistry Co., Ltd.

TruDi Shaver Blade

Acclarent, Inc.

Advanced LumFix Spinal Fixation System

CG Bio Co., Ltd.

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

Shanghai Handy Medical Equipment Co., Ltd.

IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10

Shenzhen Koli Technology Co.,Ltd

Collagen Dura Regeneration Membrane - Repair

Collagen Matrix, Inc.