EOS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SINUS QUICK IT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ATLAS IMPLANT SYSTEM - WIDE PLUS

FDA 510(k)

FDA Class 2 ·Dental

I-FIX SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ACE Cannula

FDA 510(k)

FDA Class 2 ·General Hospital

NOVEL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATLAS IMPLANT SYSTEM- MINI PLUS

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

LMT-3000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEXUS CERVICAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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

COMFORT COUGH

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery