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

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    560 HIGH DEFINITION CAMERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SERVICE, CCU, HIGH DEF, 560P, 2NDGEN

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 28, 2023

    TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·December 11, 2020

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 16, 2013

    LTV

    FDA Adverse Event
    Death ·CAREFUSION 203, INC.·Product code CBK·April 19, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018