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

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    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    HNM Medical

    FDA UDI
    HNM STAINLESS, LLC.·00842962107454·METZENBAUM SCISSORS, 4 1/2", DELICATE, STR

    HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 9, 2013

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 15, 2011

    VITALITY VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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

    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