Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

ELA MEDICAL UNILITH 7540 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS MODEL 4001

FDA 510(k)

FDA Class 3 ·Cardiovascular

FOCUS J81F, J83F, J41F, J43F PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEAD #PMA F 860

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860

FDA 510(k)

FDA Class 3 ·Cardiovascular

PULSE GENERATOR MODEL 61 AND 128

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MULTILITH PULSE GENERATOR #1140

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH 3 MODELS 7580/7583/7680/7683

FDA 510(k)

FDA Class 3 ·Cardiovascular