BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Digital Automatic Wrist Blood Pressure Monitor MD3200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05711584055410·SA5 ITEPD, WL R BE SAPHIRA 5

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837086282·

    PROPATCH SOFT TISSUE REPAIR MATRIX

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

    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    PENUMBRA COIL 400

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·June 24, 2011

    Precise Digital Accelerator Delivery of radiation to defined target volumes

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

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    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