510(k) Device Clearances

Elecsys Anti-HBc IgM

Roche Diagnostics

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H;

3M Company

Synthecure Synthetic Calcium Sulfate

Austin Medical Ventures, Inc.

TeraRecon Aorta.CT (1.1.0)

Terarecon,Inc.

LZI Buprenorphine II Enzyme Immunoassay

Lin-Zhi International, Inc.

Aspiron S ACP System

U&I Corporation

Contour ProtégéAI+

Mim Software, Inc.

Anteralign Spinal System with Titan nanoLOCK Surface Technology

Medtronic Sofamor Danek USA

Medline Smoke Evacuation Shroud

Medline Industries, Inc.

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle,

Jiangsu Kangbao Medical Equipment Co., Ltd.

KALA Red Light Face Mask (KALA-01)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Anterion

Heidelberg Engineering GmbH

HERA Interlocking Intramedullary Nailing System

ZheJiang Decans Medical Devices Co., Ltd.

SIMDA abutment

Simda Co., Ltd.

TearCare MGX System

Sight Sciences, Inc.

Capiox iCP Centrifugal Pump

Terumo Cardiovascular Systems Corporation

TAP Lancet

Yourbio Health, Inc.

Pen Injector

Wuxi Nest Biotechnology Co., Ltd.

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

Encore Medical L.P.

Lithoblast Single Use Holmium Laser Fibers

Dawell Medical, LLC

Paradigm System

Proprio, Inc.

Identity Shoulder System

Zimmer, Inc.

TFX-LT2000 Therapy Light

Toefx, Inc.

Cannulated PsiFGuard

Spineguard

ROVO Mechanical Thrombectomy Device

2mg, Inc.

Hemoblock_S (Prescription); Hemoblock_S (OTC)

Incore Co., Ltd.

RODEO Telescopic Nail

Orthofix Srl

TRELLIS™ SI Joint Fusion System

Orthofundamentals, LLC

Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)

Careglove Global Sdn. Bhd.

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

Saneso, Inc.