BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenZ ST 98x18 ML B3

    FDA UDI
    ARGEN CORPORATION, THE·D818123351·Dental porcelain/ceramic restoration kit

    Logical G-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215024246·

    Logical G-Series Acetabular Shell

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215052645·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111233510·50mm Acetabular Cup

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970614·

    DMC COMPOSITE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    MAGIC INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nifty Fifty VENTO Cup

    FDA UDI
    AMPLITUDE SAS·03701089502306·

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

    SENSITHERM PROBE

    FDA Adverse Event
    Injury ·FIAB S.P.A.·Product code FLL·July 10, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 26, 2014

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·June 8, 2011

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016