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

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    Minuteman G5 MIS Fusion Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046741·NTS Slot Tube, 18x80mm Beveled

    SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPEX SPORT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·February 15, 2018

    COCR FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JDI·March 1, 2018

    COCR FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 15, 2018

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 23, 2008

    ENDURANT ILIAC STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 10, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 8, 2013

    COMP RVS HMRL TI TRAY 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·September 1, 2017

    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025