BEUDAMED
    1,369 results · 43ms · Sources: EU EUDAMED, US FDA

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ISOFLEX S PERMANENT PACING LEAD MODELS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 and 5 VR-T, Ilivia Neo 7 VR-T DX, and Intica Neo 7 and 5 VR-T DX

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

    TRUPCR® Bacterial / Fungal DNA Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·2 devices

    TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® BS DNA Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® Panel Extraction Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

    TRUPCR® BS DNA Extraction Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

    TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

    Analyzer, Medical Image

    FDA Pre-Market Approval
    FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD

    DEX SURGICAL

    System producer
    🇫🇷 France

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T DF-1 ProMRI, Ilivia Neo 7 VR-T DX DF-1 ProMRI, Intica Neo 5 VR-T DF-1 ProMRI, Intica Neo 5 VR-T DX DF-

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Kainox VCS; Linox TD 65/18 & 65/16; SD 75/18, 65/18, 65/18, 60/16; T65, S75,S65, S60; S DX 65/17; S DX 65/15; Protego DF

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER