BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    SPQ TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    GAUZE SPONGE, X-RAY DETECTABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ARGEDENT Y-86 DENTAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 28, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 2, 2011

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 24, 2014

    4.5MM NARROW LCP® PLATE 8 HOLES/152MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code KTT·January 21, 2014

    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

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

    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024