BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Arthrex BioSync® Bone Wedge

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131288219·NERA2 PRO, DESIGNRITE 10 WL SOR

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111131752·SKLHN REYNOLDS SCISS CVD 7"

    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ALCO-SCREEN 02

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GDC POWER SUPPLY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 20, 2017

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 1, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 8, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 7, 2013

    HIP HEAD, 10/12 TAPER,28MM,+0MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 30, 2011

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 5, 2013

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 26, 2017

    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

    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