BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Nitinol Compression Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011811·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 23

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613085414·Antrum Curette, 1.5mm x 6mm Cup, Overall Length...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430210·Rod Template, 500mm

    UNIT, PHACOFRAGMENTATION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 17, 2024

    UNK TISSUE EXPANDER

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code LCJ·October 25, 2023

    JETSTREAM SC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 3, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MPROC, VILLALBA·Product code MHY·June 23, 2011

    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·August 24, 2016