WAVELIGHT IDAS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MedicCO2LON (MedicCO2LON)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IDAS INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS

FDA 510(k)

FDA Class 2 ·Radiology

IDA-4 AND IPT-MC

FDA 510(k)

FDA Class 2 ·General Hospital

Neuralytix iD3 System (NTX-9001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Health-e-Connect System with IDA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AERONEB SOLO; AERONEB SOLO ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology