Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

CBC-CAL/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

HEMATOLOGY CALIBRATOR S-CAL

FDA 510(k)

FDA Class 2 ·Hematology

TECH-CAL(TM)/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

TRI-COUNT CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTOLOGY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

FDA 510(k)

FDA Class 2 ·Hematology

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXICAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

RAICHEM SPIA C4 REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC

FDA 510(k)

FDA Class 2 ·Radiology

LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPYGLASS IRRIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery