SOMATOM FLASH DS

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

MODULARIS VARIOSTAR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

XPERCT

FDA 510(k)

FDA Class 2 ·Radiology

SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

FDA 510(k)

FDA Class 2 ·Immunology

MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

6248VAL ADJUSTABLE VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXL ANEM CAL, MODEL RC640

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

MODEL 9210 DELIVERY CATHETER, MODEL 9210

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Immunology