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

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    OLYMPUS ISE MODULE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 25, 2012

    INDISTRIP (STERILIZATION PROCESS INDICATOR)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CREATININE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOLETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 25, 2010

    REJUVENATE STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·December 17, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·Product code OZO·June 19, 2014

    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012