BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    PICC Tip Positioning Aid

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Acetabular Reamers

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039158·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121522610·Bridgeback Acetabular Reamer, Size 61mm

    MODIFICATION TO: VERTE-STACK SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 7, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·June 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    ALINITY I SYPHILIS TP REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LIP·October 16, 2025

    ALINITY I ANTI-HCV REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code MZO·October 16, 2025

    ARCHITECT ANTI-HBC II

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOM·October 16, 2025

    ARCHITECT HBSAG QUALITATIVE II

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 16, 2025

    ARCHITECT SYPHILIS TP

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LIP·October 16, 2025

    ALINITY I ANTI-HBC II REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOM·October 16, 2025

    ARCHITECT ANTI-HCV

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code MZO·October 16, 2025

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LOM·October 16, 2025

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014