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

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    URESIL SUMP DRAINAGE CATHETER

    FDA 510(k)
    FDA Unclassified ·Unknown

    ZAVATION

    FDA UDI
    Zavation LLC·00842166152236·WHITNEY 14mmx16mm , 5deg , 09mm

    STRYKER ALL SUTURE ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEM VITAMINS (100X

    FDA 510(k)
    FDA Class 1 ·Hematology

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 2, 2021

    ITREL 3

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·January 17, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·December 13, 2010

    ZEPHYR DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015