BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER

    FDA 510(k)
    FDA Class 2 ·Dental

    HYDROSET

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154275007·5CC HYDROSET INJECTABLE CEMENT

    S53516 10mL REF 943-905 Electrode Cleaner

    FDA UDI
    Radiometer Medical ApS·05700699439055·Electrode Cleaner (pH, pO2, pCO2) for BPH5, ABL...

    Stitch Cerclage – Suture Tapes

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRAUMA CARE EVALUATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 28, 2010

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 5, 2013

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 18, 2014

    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

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015