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

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    FLUOR-B MEL A DIRECT FLUORESCENT ANTI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTRA-LOCK DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ERGOLINE

    FDA Adverse Event
    Malfunction ·JK PRODUCTS GMBH·Product code LEJ·May 21, 2014

    PROTACK 5MM INSTRUMENT

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code KOG·April 28, 2010

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 15, 2012

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    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