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

Clear Moves Aligner

FDA 510(k)

FDA Class 2 ·Dental

XBeam (v2)

FDA 510(k)

FDA Class 2 ·Radiology

Photoelectric Therapy System

FDA 510(k)

FDA Class 2 ·Radiology

X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)

FDA 510(k)

FDA Class 2 ·Radiology

Daye Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology