BEUDAMED
    36 results · 24ms · Sources: EU EUDAMED, US FDA

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    Denver orange/schw/ora Sprint/Ri-Nub/Nyl S

    Device
    EU MDR · Eu Md Class 1 ·Thanner GmbH·On the market

    BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)

    FDA Enforcement
    Class II ·Ongoing·PTW-FREIBURG·September 20, 2023

    DORA Digitale Orthopädie Anwendungen GmbH

    Manufacturer
    🇩🇪 Germany

    BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cranio-caudal fixation unit CC-GE

    Device
    EU MDR · Eu Md Class 1 ·NORAS MRI products GmbH·On the market·1 country

    iLoop Interventional Coil 0.55T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Mandibula 15-Channel Dental Coil 1.5T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    BI 6 Comfort 3T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Breast BI Coil Set 0.55T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Breast BI 7 MR Coil Set 3T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Breast BI 7 MR Coil Set 1.5T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    4 Ch BI Breast MR Coil Kit 3T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    4 Ch BI Breast MR Coil Kit 1.5T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Breast Basis Set

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Encompass 15 Channel MRI Head Coil - 3T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    Mandibula 15-Channel Dental Coil 3T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    BI 6 Comfort 1.5T

    Device
    EU MDR · Eu Md Class 2a ·NORAS MRI products GmbH·On the market·1 country

    mMR Breast Basis Set 1,5T/3T

    Device
    EU MDR · Eu Md Class 1 ·NORAS MRI products GmbH·On the market·1 country

    Cranio-caudal fixation unit CC-320-PLUS

    Device
    EU MDR · Eu Md Class 1 ·NORAS MRI products GmbH·On the market·1 country

    AV/BRA/R

    Device
    EU MDR · Eu Md Class 2a ·Serumwerk Bernburg AG·On the market·5 countries