BEUDAMED
    1,479 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MYCARELINK PATIENT MONITOR MODEL

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MYCARELINK PATIENT MONITOR

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink Programmer (Model 2090), Encore Programmer (Model 29901)

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY,

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Pulse Generator Test Magnet

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·PSW 2303.U, NEO 2303.U

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/D

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, C

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK PRX AND VENTAK MINI SYSTEMS

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·REVEAL LINQ SOFTWARE MODEL SWO26

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATION PSA

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir™ VR Leadless Pacemaker, Aveir™ DR Leadless Pacemaker

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE FPSA ASSAY

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE AFP ASSAY

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE PSA ASSAY