RUBELISA IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

CYTOMEGELISA STAT

FDA 510(k)

FDA Class 2 ·Microbiology

VARICELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - MOBILE LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA

FDA 510(k)

FDA Class 2 ·General Hospital

Ripley Spinal Screw System by SAGICO

FDA 510(k)

FDA Class 2 ·Orthopedic

POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

QUAD-LINK RETRACTABLE MOUNT

FDA 510(k)

FDA Class 2 ·Physical Medicine

MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQMap 3D Imaging and Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ablacath™ Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIRMap Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sphere-9Dx Diagnostic Catheter (AFR-00009)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Carto Octaray Mapping Catheter with Trueref Technology

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONSTELLATION CATHETERS, MODEL 8031M

FDA 510(k)

FDA Class 2 ·Cardiovascular

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRIMAP ADAPTER CONNECTOR (MAC)

FDA 510(k)

FDA Class 2 ·Cardiovascular