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

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·FLOW MIC SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·3M BRAND MICROBIAL PROFILE SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

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

PRIMUS

FDA 510(k)

FDA Class 2 ·Radiology

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

MX MEVATRON

FDA 510(k)

FDA Class 2 ·Radiology

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