EFF-EFFNER BULBS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL

SANICURE DISPOSABLE CURING PROBE

FDA 510(k)

FDA Class 2 ·Dental

SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)

FDA 510(k)

FDA Class 2 ·Orthopedic

VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EBERLE SHAVER SYSTEM ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES

FDA 510(k)

FDA Class 2 ·Orthopedic

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

12-LEAD GLOVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

VOLUME COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3.7MM/5.0MM DYNAMIC LOCKING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat