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

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    PRIMED RIGID CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SINGLE USE PAPER FILTER WITH INDICATOR

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code FRG·January 30, 2019

    VIASPAN

    FDA Adverse Event
    Other ·FRESENIUS KABI AUSTRIA GMBH·Product code KDL·March 26, 2012

    NOVA 13 ANALYZER, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VA-LCP PROX-TIB-PL3.5 LARGE BEND R 4HO L

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·February 5, 2013

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·July 18, 2014

    VENTAK PRIZM

    FDA Adverse Event
    Injury ·CPI PLANT - ST. PAUL·Product code LWS·January 3, 2011

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    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