BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942105694·POST PARTUM C SECTION KIT

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837089030·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EK DELIVERY DEVICE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 8, 2024

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 7, 2013

    MAXTORQUE ZP

    FDA Adverse Event
    Injury ·ORTHOHELIX SURGICAL DESIGN·Product code HWC·June 29, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014