SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)

FDA Class 2 ·Radiology

HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE

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

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'NO-BOIL' VITAMIN B12 KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIAISON Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITAMIN B12 - NO-BOIL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMBOSTAT - NO-BOIL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISTA B12 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITAMIN B12 RADIOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry