BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    BIAFINE

    FDA 510(k)
    FDA Unclassified ·Unknown

    HYDROSET

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154275014·10CC HYDROSET INJECTABLE CEMENT

    Retraxil

    FDA 510(k)
    FDA Unclassified ·Unknown

    COULTER MEAN PLATELET VOLUME CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NPT·October 7, 2025

    UNK CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·April 8, 2019

    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.

    FDA Enforcement
    Class II ·Terminated·Stryker Craniomaxillofacial Division·September 4, 2013

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·February 5, 2013

    LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·December 1, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2014

    CAPIOX ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·October 10, 2018

    ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTM·June 28, 2019

    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code GXP·July 30, 2013

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017