AURA LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRA LOW POROSITY DACRON WOVEN PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO CARDEON AEGIS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WRP FOLEYCATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO CARDEON AEGIS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDEON ASCENDING BALLOON CANNULA (ABC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

FDA 510(k)

FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS EDGE (TM)DILATATION CATHETERS

T-FIX™ 3DSI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOL Spinal Interbody System, EVOS Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

CUTTING EDGE SPINE INTERBODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOS Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOS Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOL® ha – Hyper C Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOL ha - D Lateral Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

QUIX DIGITAL RADIOGRAPHIC UPGRADE

FDA 510(k)

FDA Class 2 ·Radiology

EVOL Spinal Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

T-FIX® 3DSI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic