BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·DEMA IPGS/ C & T SERIES IPGS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED RPM CATHETER

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·PRODIGY

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

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY OF CRT-DS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Tendril SDX, ST, STS and OptiSense LV leads

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK ICD Family

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR/SR MRI IPG, Sphera DR/SR MRI IPG

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·DEMA IPGS/C & T SERIES IPGS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cobas TaqMan HBV Test, Cobas AmpliPep/Cobas, TaqMan HBV Test, v2.0, Cobas AmpliPrep

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·TRIDYNE VASCULAR SEALANT

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

    FDA Pre-Market Approval
    FDA Class 3 ·DYNAGEN ™ CRT-D: G150, G151, G154 DYNAGEN ™ X4 CRT-D: G156, G158; INOGEN ™ CRT-D: G140, G141 INOGEN ™ X4 CRT-D: G146, G1

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM THERAPY SYSTEM (URINARY)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Infusion System

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ELCA Laser Catheters

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses