ERB ENDORECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GDS ENZYMATIC ACETAMINOPHEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EDGE SYSTEMS STERILE TUBING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GDS ENZYMATIC SALICYLATE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DEL SOL BLUE LIGHT THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

CORONARY VEIN GRAFT TAG MARKER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

FDA 510(k)

FDA Class 2 ·Anesthesiology

EVOL Spinal Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

T-FIX® 3DSI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic