BEUDAMED
    10,000 results · 34ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PULSAR/DISCOVERY/MERIDIAN

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DF-1 CONNECTOR PORT PIN PLUG,IS-1 CONNECTOR PORT PIN PLUG KIT,SPRINT QUATTRO LEAD,SUBCUTANEOUS LEAD,TRANSVENE CS/SVC LEA

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MAXIMO II, SECURA & VIRTUOSO II DR/VR ICDS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGYST PULSE GENERATORS MODEL 7026/7027

    Catheter, Percutaneous, Long Term, Intraspinal

    FDA Pre-Market Approval
    FDA Class 3 ·PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Wolverine Coronary Cutting Balloon

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra TPS

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Essentio, Proponent, Accolade, and Altrua 2 Non-MRI Pacemakers

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

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

    FDA Pre-Market Approval
    FDA Class 3 ·Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead