SCARLET AL-T

FDA 510(k)

FDA Class 2 ·Orthopedic

Juliet® Ti LL Lumbar Interbody Device

FDA 510(k)

FDA Class 2 ·Orthopedic

SCARLET® AC-T Secured Anterior Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

PERLA® TL Posterior Thoraco-lumbar Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Juliet® Ti LL Lumbar Interbody Device

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

SPINEART Navigation Instrument System

FDA 510(k)

FDA Class 2 ·Neurology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER

3MENSIO WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QIVA

FDA 510(k)

FDA Class 2 ·Cardiovascular

3mensio Workstation

FDA 510(k)

FDA Class 2 ·Radiology

CAAS II RVA

FDA 510(k)

FDA Class 2 ·Radiology

FETAL CARE MONITOR ANTEPARTUM 1500

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CAAS II QVA

FDA 510(k)

FDA Class 2 ·Radiology

CAAS INTRAVASCULAR

FDA 510(k)

FDA Class 2 ·Radiology

CAAS A-Valve

FDA 510(k)

FDA Class 2 ·Radiology

HEMISPHERE MULTIPLANE ENDORECTAL PROBE

FDA 510(k)

FDA Class 2 ·Radiology

CAAS QVA 3D, CAAS QCA 3D

FDA 510(k)

FDA Class 2 ·Radiology