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

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    PYR/ESCULIN DISK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STIWELL MED4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996

    ENTERRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·June 18, 2014

    RUSCH 6FR 100% SILICONE FOLEY CATHETER 1.5CC

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code EZL·October 5, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·December 20, 2012

    BALANCE PRIMARY HIP 9 X150 RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·July 14, 2020

    M2A-TAPER LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 21, 2019

    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