Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor-Saline-Filled and Spectrum Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

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

FDA Pre-Market Approval

FDA Class 3 ·AIA-PACK PSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AFP-EIA

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ER-EIA MONOCLONAL

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·PGR-EIA MONOCLONAL

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

Hepatitis Delta Serological Reagents

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ANTI-DELTA EIA

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT HBE (RDNA) EIA

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC EIA

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT HBE (RDNA) EIA

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·ICP TELE-MONITOR & ICP TELE-SENSOR

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)

Monitor, Intracranial Pressure, Implanted

FDA Pre-Market Approval

FDA Class 3 ·COSMAN ICP TELE-SENSOR(R)