IRENE Cannulated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Reusable SpO2 Sensors, Disposable SpO2 Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

CO2 Mainstream Module

FDA 510(k)

FDA Class 2 ·Anesthesiology

Disposable medical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

FDA 510(k)

FDA Class 2 ·Neurology

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Philips CT 3500

FDA 510(k)

FDA Class 2 ·Radiology

Denture Base Resin (PN-Denture (Red, White))

FDA 510(k)

FDA Class 2 ·Dental

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electronic Muscle Stimulator (Model MP01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Angiography Injector

FDA 510(k)

FDA Class 2 ·Cardiovascular

Leg Massager (Models:RP-ALM070H, RP-ALM071H)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Biofeedback Nerve and Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric wheelchair (KR-8807)

FDA 510(k)

FDA Class 2 ·Physical Medicine

GlucoSure HT Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry