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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA FPSA ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Anti-HBc IgM

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® /IMMULITE® 1000 Free PSA and IMMULITE® 2000 Free PSA

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Anti-HBc

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Anti-HBs

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.

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

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Hip System

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·Implantable Miniature Telescope (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·Implantable Miniature Telescope (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X