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

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    IO-TOME DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    8960 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020723·8960 PED SM MASK W/1420A 2W

    24PW - Piedmont Natural Gas - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588130736·24PW - Piedmont Natural Gas - Poly White

    INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SUPER CHAIR FOR KIDS BY ORION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

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

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 24, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015