Refusal Actions by FDA as Recorded in OASIS for United States

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


    Ats Medical
    Plymouth, MN  55447-5473                       MIN-DO  H42-0093069-5/1/1
    74L--WQ   HEART VALVES
                        04-FEB-2008                        NO PMA

    Steiner Transocean Ltd
    Middx , GB HA36BZ                              FLA-DO  MA7-0683759-2/1/1
    76M--AU   GENTLE WHITE PROFESSIONAL KIT
                        05-FEB-2008                        NOT LISTED
                                                           REGISTERED
                                                           NO 510(K)

    Mabis Healthcare, Inc.
    Waukegan, IL  60085                            NYK-DO  110-1034966-6/1/1
    80K--YZ   Sterile Bulb Syringe
                        05-FEB-2008                        POSS N/STR
                                                           DV QUALITY

    Achilles Natural Health Mart
    Northfield, NJ  08225-9998                     CIN-DO  110-1703236-4/1/1
    66VCA99   PROCAINE GH9 60 CAPSULES HERBAL REMEDY, US GOODS RTNG, NOT D
                        07-FEB-2008                        UNAPPROVED

    Ciba Vision Corporation
    Duluth, GA  30097-1518                         NOL-DO  112-1171758-5/2/1
    86L--PL   854068882710 DAILY CONTACT LENS
                        07-FEB-2008                        NO 510(K)

    Boss Instruments, Ltd.
    Earlysville, VA  22936-2461                    NYK-DO  110-1489419-6/1/1A
    79M--DM   Surgical Instrument- Backbitter
                        08-FEB-2008                        NOT LISTED
                                                           NO 510(K)

    Boss Instruments, Ltd.
    Earlysville, VA  22936-2461                    NYK-DO  110-1489419-6/1/1B
    78F--CL   Surgical Instrument-Post Nasal Biopsy FCP
                        08-FEB-2008                        NOT LISTED
                                                           NO 510(K)

    Whitehall Robins Laboratories
    Madison, NJ  07940-1027                        NYK-DO  T77-1038218-7/5/1
    62GBO99   MADE IN USA PREP-H OINTMENT
                        11-FEB-2008                        NOT LISTED

    Whitehall Robins Laboratories
    Madison, NJ  07940-1027                        NYK-DO  T77-1031604-5/4/1
    62GBO99   MADE IN USA BY WHITEHALL ROBINS PREP-H OINTMENT
                        11-FEB-2008                        NOT LISTED

    Global Rx Inc
    Efland, NC  27243-9624                         LOS-DO  AEK-7744903-7/1/1
    62ICC99   DACOGEN(MEDICATION)(FORMAL ENTRY REQUESTED BY FDA)
                        12-FEB-2008                        UNAPPROVED

    CyberWize.com
    Sarasota, FL  34232-6244                       NYK-DO  110-1234874-0/1/1
    54FCL12   TUNGUSKA JUICE
                        14-FEB-2008                        DIETARYLBL
                                                           HEALTH C

    Robinson Pharma, Inc.
    Santa Ana, CA  92704                           LOS-DO  ES2-0102287-9/1/1
    54YCZ99   Growth Potential Vitamin Powder
                        22-FEB-2008                        LIST INGRE
                                                           LABELING
                                                           UNAPPROVED

    Pharmavite LLC dba Nature Made
    San Fernando, CA  91340-1460                   LOS-DO  EE6-0092089-0/1/1
    54YBA99   AGR VITAMINS RETURNING BECAUSE OF REJECTED SHIPMENT//40008 C
                        22-FEB-2008                        MFR INSAN

    Score Intl Inc
    Sanford, FL  32771-6602                        CIN-DO  AEK-9413309-3/1/1
    76E--JB   DENTAL HANDPEICE
                        25-FEB-2008                        NOT LISTED
                                                           REGISTERED

    Pinnacle Foods Group
    Jackson, TN  38301-5031                        NYK-DO  144-1386954-9/1/1
    12CGT06   FROZEN CHEESE PIZZA
                        25-FEB-2008                        UNSAFE COL
                                                           LACKS N/C

    Physical Electronics USA Inc
    CHANHASSEN, MN  553179384                      NOL-DO  112-0017033-3/1/1
    95L--22   861124416140  Laser MOD 50-096 PS-X Ray CE
                        25-FEB-2008                        NON STD

    Mcdavid Knee Guard Inc
    Woodridge, IL  60517-4909                      NOL-DO  112-0017372-5/1/1
    79K--GX   734726595559  BANDAGE
                        25-FEB-2008                        NOT LISTED

    Palomar Medical Products, Inc.
    Burlington, MA  01803-4107                     NOL-DO  112-0022047-6/1/1
    79G--EX   862171973716 STARLUX HANDPIECE
                        25-FEB-2008                        NON STD

    Colgate Palmolive Co
    New York, NY  10022-7402                       NYK-DO  DP4-0419452-5/2/1
    63RAJ04   TOOTHPASTE
                        27-FEB-2008                        NOT LISTED
                                                           UNAPPROVED

    JB Laboratories, Inc.
    Holland, MI  49424-8220                        LOS-DO  BUY-0009801-4/1/1
    54YCY99   IMPORT FOR EXPORT NUTRITIONAL SUPPLEMENTS WILL BE RELABLED &
                        28-FEB-2008                        DIETARYLBL
                                                           NO ENGLISH
                                                           NUTRIT LBL