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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim SCS Neurostimulation System FW

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB FW TORIC (LIDOFILCON) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB FW TORIC (LIDOFILCON) CONTACT LENSES

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

Solution, Removal, Carries

FDA Pre-Market Approval

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

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled and Spectrum Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED & SPECTRUM BREAST IMPLANTS