Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

SR-8230, SR-8230S Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

U60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

LED Facial Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AccuPoint Electrode

FDA 510(k)

FDA Class 2 ·Neurology

CuringPen Dental Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Sterile Hypodermic Needle for Single Use

FDA 510(k)

FDA Class 2 ·General Hospital

Pressure Therapy System PT1003

FDA 510(k)

FDA Class 2 ·Physical Medicine

Synvitro Hyadase

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electronic Stethoscope

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology