MEDTRONIC ENERTRAX MODEL 7100

FDA 510(k)

FDA Class 3 ·Cardiovascular

GENERATOR, PULSE, MODEL 5997

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSE GENERATORS, MODELS 5972/5973

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5985 PACEMAKER PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEART SYNC, MODELS C-100 AND T-100

FDA 510(k)

FDA Class 3 ·Cardiovascular

THERMASCAN

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

MODIFICATION OF ABL MIC-10 PRECEPT SYS

FDA 510(k)

FDA Class 3 ·Unknown

API UNISCEPT MIC

FDA 510(k)

FDA Class 3 ·Unknown

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·cobas HBV Test

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE (LN 6L22)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS FREE PSA