BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

FDA 510(k)

FDA Class 2 ·Neurology

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA .014 RX Pheripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tamarin Blue PTCA RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014 RX Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Globalcare Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

GCE704 Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Electric Breast Pump, model: YM-8166

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OTC EMS STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Non-invasive EEG Sensor

FDA 510(k)

FDA Class 2 ·Neurology

Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

aprevo® transforaminal lumbar interbody fusion device

FDA 510(k)

FDA Class 2 ·Orthopedic