MAGNESIUM STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

SERAGARD VASCULAR ACCESS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

EVOL® -SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOL® ha-C Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS EDGE(TM) CORONARY DILITATION CATHETER