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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE(R) TC CARDIAC ABLATION SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP (LN 7A48)

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval

FDA Class 3 ·IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE

Artificial Heart

FDA Pre-Market Approval

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

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CPI SWITCH BOX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT