CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

Hemo Control (optional Add Pack Hemo Control DM)

FDA 510(k)

FDA Class 2 ·Hematology

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

STATUSFLOW

FDA 510(k)

FDA Class 2 ·Hematology

ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD-CAL PLUS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SETPOINT CHEMISTRY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTRA 5D

FDA 510(k)

FDA Class 2 ·Hematology

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology