BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Viva, Brava, Protecta, Protecta XT, Concerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl

    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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Viva, Brava, Protecta, Protecta XT, COncerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK VITALITY AVT AICD, MODELS A135 AND A155, MODEL 2920 PROGRAMMER WITH MODEL 2812 APPLICATION SOFTWARE VERSION 1.2

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS MULTI-LINK RX DUET CORONARY STENT SYSTEM AND THE ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY

    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 ·MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve and Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SELECT MODELS OF SYNCHRONY, TRILOGY AND AFFINITY FAMILY OF PACEMAKERS, SOLUS,ADDVENT, SOLUS II, SYNCHRONY,PHOENIX III, Y

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FO

    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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·AT500 DDDRP PACING SYSTEM (MODEL AT500) AND MODEL 9968 SOFTWARE POST-MARKET (RESPECT): ADDING THE ENRHYTHM MODEL P1501DR

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A