BEUDAMED
    9 results · 36ms · Sources: EU EUDAMED, US FDA

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    CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GAMBRO HEMOFREEZE-BAG

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPIN CHEM REAGENT, DETERMINATION OF AST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    NEPTUNE 2 ROVER ULTRA (120V)

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·November 14, 2012

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014