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

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    Osstem Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 4, 2024

    MODIFICATION TO TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROFEMUR Z REVISION HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 25, 2011

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 4, 2014

    IMMULITE 2000

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·July 12, 2013

    ARCHITECT ANTI-HCV REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code MZO·January 17, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018