Refusal Actions by FDA as Recorded in OASIS for Germany
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
S & S Messelogistik Gmbh
Herzogenaurach , DE 91074 CHI-DO 408-1151917-9/10/1
80N--SB MEDIKIT AID POUCH
03-DEC-2007 NOT LISTED
REGISTERED
S & S Messelogistik Gmbh
Herzogenaurach , DE 91074 CHI-DO 408-1151917-9/2/1
95L--22 LASER POINTERS GIFTS FOR SHOW POWER GEN NEW ORLEANS 2007
03-DEC-2007 NON STD
NO REGISTR
Saleh Ahmed Bin Afif Cosmetics Factory
Unknown , SA MIN-DO G08-0024141-9/4/1
53CY-06 EYE MAKEUP PREP
04-DEC-2007 COSM COLOR
American Dental Systems
Vaterstatten , DE D85591 NOL-DO 112-0135380-5/1/1
76E--MO 951326964146-KNIFE
05-DEC-2007 NOT LISTED
Glaxosmithkline
Herrenberg , DE 71083 NOL-DO 112-0136468-7/1/1
64LDK67 856621672612 / DERMOXINALE
05-DEC-2007 UNAPPROVED
Inverness Medical Deutschland
Cologne , DE NOL-DO 112-0209062-0/1/1
88L--DT 861150030872 REAGENTS
06-DEC-2007 NOT LISTED
Schering Ag
Bergkamen , DE 1234 NOL-DO 112-0244565-9/1/1
64RCP99 862817806383 BIRTH CONTROL
06-DEC-2007 UNAPPROVED
Schering Deutschland Gmbh
Berlin De , DE 10589 NOL-DO 112-0312483-2/1/1
64GCA13 861149837224.PROGYNOVA
10-DEC-2007 UNAPPROVED
Emfret Analytics
Eibelstadt , DE 97246 NOL-DO 112-0459581-6/1/1
57FY-74 864257294886-MONOCLONAL ANTIBODY
12-DEC-2007 NOT LISTED
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO 112-0509889-3/1/1
53CK-02 946595640835-EYELINER
14-DEC-2007 COSMETLBLG
Roche Diagnostics Gmbh
Mannheim , DE D-68298 NOL-DO 112-0607361-4/2/1
81G--JS 858927457671/TEST REAGENT ASSAY KITS
14-DEC-2007 NOT LISTED
NO 510(K)
Bayer Schering Pha
Berlin , DE NYK-DO D99-0075628-6/1/1
64GBS19 LEVONORGESTREL
14-DEC-2007 NOT LISTED
DIRECTIONS
Bayer Ag
Leverkusen , DE D-51368 NOL-DO 112-0555370-7/1/1
66VIP99 662722654093 RIVAROZABAN
18-DEC-2007 NOT LISTED
UNAPPROVED
Indigodental
Bliedersdorf , DE 22547 NOL-DO 112-0531904-2/1/1
76E--MA 636830571535 Cristobal Opaque Powder (DENTAL CEMENT)
18-DEC-2007 NOT LISTED
NO 510(K)
American Dental Systems
Vaterstatten , DE D85591 NOL-DO 112-0546464-0/1/1
80L--DQ 951326965072/TUNNELKNIFE
18-DEC-2007 NOT LISTED
American Dental Systems
Vaterstatten , DE D85591 NOL-DO 112-0546464-0/1/3
80L--DQ 951326965072/MIRROR
18-DEC-2007 NOT LISTED
American Dental Systems
Vaterstatten , DE D85591 NOL-DO 112-0546464-0/1/2
80L--DQ 951326965072/TWEEZER
18-DEC-2007 NOT LISTED
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 101-7607787-2/2/1
53CK-02 TIGI EYE PENCIL FUNSTICK - Blue
19-DEC-2007 POISONOUS
Eppendorf Geratebau Netheler + Hinz Gmbh
Hamburg , DE 22339 FLA-DO EQ6-0007090-6/1/1
80L--DQ LAB EQ FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR EXPORT O
20-DEC-2007 REGISTERED
NO 510(K)
Eppendorf Geratebau Netheler + Hinz Gmbh
Hamburg , DE 22339 FLA-DO EQ6-0007091-4/1/1
80L--DQ LAB EQ FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR EXPORT O
20-DEC-2007 REGISTERED
NO 510(K)
Hauptner Herberhoiz
Solingen , DE 42651 NOL-DO 112-0553507-6/1/1
68XYY99 790397338824 VET INSTRUMENTS
21-DEC-2007 NOT LISTED
Biomun Bertriebsgesllschaft Mbh
Rostock , DE 18069 NOL-DO 112-0677565-5/1/1
54AYY99 942922207147 DIETARY SUPP.
27-DEC-2007 NO ENGLISH
Morcher Gmbh
Stuttgart , DE 70374 NOL-DO 112-0671373-0/1/1
86H--QL 946657779222/INTRAOCULAR LENS
27-DEC-2007 NO PMA
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO 112-0644364-3/2/1
53YY-99 864076384546 LIPLINER
27-DEC-2007 CSTIC LBLG
COSMETLBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 NOL-DO 112-0644364-3/1/1
53CY-02 864076384546 EYELINER
27-DEC-2007 CSTIC LBLG
COSMETLBLG