Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC,DISCOVISC

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·Watchman Left Atrial Appendage Closure Technology

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL)

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

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

FDA Pre-Market Approval

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

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR & DR ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR, Esprit SR, Esprit DR

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

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

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

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

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accessory Wrench Socket Cap Brady/Tachy

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP) Assay

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP) Assay