80 results · 19ms · Sources: EU EUDAMED, US FDA

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis

Device, Impotence, Mechanical/Hydraulic

FDA classification
FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic

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

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·Gel-One

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)

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

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

Oximeter, Fetal Pulse

FDA Pre-Market Approval
FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING