INSTRUMENT ACTUATING DEVICE (IAD)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Allergan Botox Needle Electrode

FDA 510(k)

FDA Class 2 ·Physical Medicine

NATUS WARMETTE BLANKET AND DUAL CABINETS

FDA 510(k)

FDA Class 2 ·General Hospital

Grass® MR Conditional/CT Cup Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Myoject Luer Lock Needle Electrode

FDA 510(k)

FDA Class 2 ·Physical Medicine

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arise™ UHP Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k)

FDA Class 2 ·Physical Medicine

AERONEB SOLO; AERONEB SOLO ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPTIAM SYPHILIS-G ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery