BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Zephyr Vascular Compression Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORATION MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013

    VISTA BASIC SAFETY INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 20, 2011

    ARTHROCARE FOOT CONTROL

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code GEI·September 9, 2008

    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