BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    STRADA CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

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

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

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 14, 2024

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 22, 2013

    UNKNOWN DEPUY SZ 5 RP CVD INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 3, 2008

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016