SIGNEX

FDA 510(k)

FDA Class 2 ·Orthopedic

Ortho MI System

FDA 510(k)

FDA Class 2 ·Dental

ChM 4.5mm Cortical screws

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIBONE CERAMIC DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ZIBONE ZIRCONIA BLOCKS

FDA 510(k)

FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Yamahachi Pink CAD/CAM Disk

FDA 510(k)

FDA Class 2 ·Dental

Certa Catheter

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ez3D Plus

FDA 510(k)

FDA Class 2 ·Radiology

Optimus Neuro System

FDA 510(k)

FDA Class 2 ·Neurology

OPTIMUS CMF SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORIGINEEDLE(TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENTREE NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIANEN CYCLIC-AMP RADIOIMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry