SYNTHES CHRONOS COMPOSITE

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)

FDA 510(k)

FDA Class 2 ·Neurology

UREA N STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) PRETEST 8A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

WAKO(TM) PRETEST 5A

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

WAKO(TM) AUTOKIT GPT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

WAKO(TM) IGG-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

GIT SERUM-FREE MEDIUM FOR CELL CULTURE

FDA 510(k)

FDA Class 1 ·Hematology

WAKO(TM) IGM-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

MAGNESIUM STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) UIBC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDA-MV PACING SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES

Hi-Dow Wireless TENS/EMS System (Model HD-5N)

FDA 510(k)

FDA Class 2 ·Neurology

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

FDA 510(k)

FDA Class 2 ·Neurology