BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    ABPMpro

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111139703·SKLARLITE OP SCISS SB ST 4 1/2

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102114·SHEPHERD CAPSULE POLISHER RIGHT

    POWDERED VINYL EXAM GLOVES, WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AsoAligner

    FDA 510(k)
    FDA Class 2 ·Dental

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD·Product code FRN·November 17, 2008

    TAXUS (TM) LIBERTÉ (TM)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 1, 2011

    PLUM LC 500 REFURB

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·September 16, 2024

    BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·December 19, 2012

    BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code GRO·October 22, 2012

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024