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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

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

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP/OB(TM) RIA KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·QUANTITOPE 125I AFP KIT AND CONTROL SERUM

BIO-PEN SRK II CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, FRONTIER II CRT-PS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ATLAS II/+, EPIC +/II/II+, CURRENT RF/+/ACCEL, FORTIFY ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·BIORA EMDOGAIN(R)

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·BIORA EMDOGAIN(R)

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·BIORA EMDOGAIN(R)

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·STRAUMANN EMDOGAIN