Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBC IMG

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X

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

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS FREE PSA

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP)

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

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA