Refusal Actions by FDA as Recorded in OASIS for Sweden

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Astrazeneca Sverige Ab
    Sodertalje , SE                                SAN-DO  112-3878754-6/5/1
    66VDY99   860766218280 BETALOC ZOK
                        14-AUG-2008                        NOT LISTED

    Maquet Critical Ca
    Solna , SE                                     NOL-DO  112-1526367-7/1/1
    74D--TM   956334644477/FILTER
                        22-AUG-2008                        NOT LISTED
                                                           NO 510(K)

    Maquet Critical Ca
    Solna , SE                                     NOL-DO  112-1526367-7/1/2
    74D--PT   956334644477/PROBE
                        22-AUG-2008                        NOT LISTED
                                                           NO 510(K)