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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EGFR Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20 DEFIBRILLATOR/ MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED OSCOR PY PACING LEADS/MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12, 20, 500, CR PLUS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T4 AND T6

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular