BEUDAMED
    463 results · 23ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense

    Tissue Adhesive For Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford Partial Knee System

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack)

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON-TB GOLD AND TB GOLD- Test (reference lab pack)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™, A

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Cap, Accessory, Plug

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY™ Spiral, Accessory, Slit Suture Sleeve, ACUITY™ X4 Straight, ACUITY™ X4 Spiral S, ACUITY™ X4 Spiral L, Slit Sutu

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·- ESSENTIO™ SR, ESSENTIO™ DR, SSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR

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

    FDA Pre-Market Approval
    FDA Class 3 ·VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Wrench

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Stabilizer

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC