DJF Intravascular Administration Set

FDA 510(k)

FDA Class 2 ·General Hospital

VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VENUS SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FOCUS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LEXUS ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·Alere NMP22 BladderChek Test

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 ELISA TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22(TM) TEST

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·MATRITECH NMP22(TM) TEST KIT

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHEK TEST

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BladderChek Test