Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Injectable Gel

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·Birmingham Hip Resurfacing (BHR) System

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·Cormet Hip Resurfacing System

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESUFACING SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM