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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RT5, Floseal NT and Floseal Hemostatic Matrix, Floseal

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54)

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

Contrast Media, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

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

FDA Pre-Market Approval

FDA Class 3 ·IMX PSAS

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc IgM (List Number 07P86)

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT HBE DIAGNOSTIC KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE / Alinity i Anti-HBc

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT TOTAL PSA

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·FREEDOM DRIVER SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE