BEUDAMED
    456 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage

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

    FDA Pre-Market Approval
    FDA Class 3 ·CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

    Catheter, Balloon For Retinal Reattachment

    FDA classification
    FDA Class 3 ·Catheter, Balloon For Retinal Reattachment

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve™ EnVeo™ R Loading System, Medtronic CoreValve™ EnVeo™ Pro Loading System, Medtronic Evolut™ Pro+ Loa

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA AND SCULPTRA AESTHETIC (INJECTABLE POLY-L-LACTIC ACID)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK PRX AICD SYSTEM

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·Liposorber LA-15 System

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 System

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM