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

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    Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Cup Forceps

    FDA UDI
    ELLIQUENCE, LLC·00846338005740·

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837106072·Static Expandable Cage Trial, 12mm x 28mm x 15m...

    FR.O.H. CALCANEUS REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONCO TRAC MODEL 1, 2, 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 28, 2011

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016