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

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    ENTERPRISE 8000X WITH INDIGO

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH POLSKA SP Z O. O.·Product code FNL·September 21, 2018

    Staple Removal Tray/Set/Kit; a sterile Rx convenience kit containing a staple remover instrument, an alcohol prep pad, a PVP prep pad and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Tray, reorder no. RS-2000, 3600 Bur Wood Drive, Waukegan, IL 60085; b)Medikmark Inc. Staple Removal Set, reorder no. SR-2000; 3600 Bur Wood Drive, Waukegan, IL 60085; c) Maxxim Medical Staple Removal Kit, reorder no. SD-2000, Distributed by Maxxim Medical, Oldsmar, FL 34677.

    FDA Recall
    Terminated ·Medikmark, Incorporated·Product code KKX·July 12, 2004

    Staple Removal Set/Kit; a sterile Rx convenience kit containing a staple remover and a gauze sponge. Theses kits were marketed under the following labels, 50 kits per case: a) Medikmark inc. Staple Removal Set, reorder no. SR-2005, 3600 Bur Wood Drive, Waukegan, IL 60085; b) Maxxim Medical Staple Removal Kit, reorder no. SD-2005, Distributed by Maxxim Medical, Oldsmar, FL 34677.

    FDA Recall
    Terminated ·Medikmark, Incorporated·Product code KKX·July 12, 2004