Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime HCV Genotype II

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE 11

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

FDA Pre-Market Approval

THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B orfe IgM (aHBcM) Assay

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ALGOVITA SPINAL CORD STIMULATION SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP/OB(TM) RIA KIT

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TRANSCAN T-SCAN 2000

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·Esteem Totally Implantable Hearing Device