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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
XXX-0134963-9/1/1 13-Dec-2005 80FMF 3004939698 DL Medica, S.A. de C.V. Mexico
 
XXX-0135098-3/1/1 13-Dec-2005 80FMF 3005441259 Sung Shim Medical Co., LTD Korea, Republic Of (South)
 
XXX-0135136-1/1/2 13-Dec-2005 80FMF 3005441532 Teresa Niz Mendez Guatemala
 
009-1584915-2/1/1 14-Dec-2005 80FMF 3004983316 Pharma Mar SA Spain
 
XXX-0135489-4/1/1 27-Dec-2005 80FMF 3005430714 GRN-jet/3 Guatemala
 
XXX-0135489-4/1/2 27-Dec-2005 80FMF 3000198132 Samkwang Industrial Corporation Korea, Republic Of (South)
 
XXX-0135008-2/1/1 28-Dec-2005 80FMF 3005438773 Bacilio Cardona Guatemala
 
XXX-0134989-4/1/2 28-Dec-2005 80FMF 3005438553 Samkwang Ind., Corp Korea, Republic Of (South)
 
XXX-0135521-4/1/1/D 28-Dec-2005 80FMF 1118880 Terumo Medical Corporation United States
 
XXX-0135235-1/1/2 28-Dec-2005 80FMF 3005170615 Terumo Medical Corporation United States
 
XXX-0135142-9/1/3 28-Dec-2005 80FMF 3001027464 UNKNOWN Guatemala
 
BPQ-5000179-6/1/1 22-Dec-2005 80FMZ 3000315977 Fanem Ltda Brazil
 
BPQ-5000136-6/1/1 22-Dec-2005 80FRN 3004028013 Arcomed Ag Switzerland
 
112-8344813-1/1/1/A 12-Dec-2005 80KIA 3003999451 Fresco Podologia S.L. Spain
 
004-3973978-0/2/1 27-Dec-2005 80KMN 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
004-3974591-0/2/1 27-Dec-2005 80KMN 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
XXX-0134413-5/1/2 13-Dec-2005 80KYZ 3005430714 GRN-jet/3 Guatemala
 
BPQ-5000136-6/2/1 22-Dec-2005 80KZD 3004028013 Arcomed Ag Switzerland
 
EQ6-0004682-3/1/1 01-Dec-2005 80LDQ 3002806904 ET Medical Devices S.p.A. Italy
 
EQ6-0004642-7/1/1 05-Dec-2005 80LDQ 3005440902 Mp Biomedicals Suisse Sa Switzerland
 
EQ6-0004503-1/1/1 05-Dec-2005 80LDQ 5833 EPPENDORF AG Germany
 
112-8493552-4/1/1 14-Dec-2005 80LDQ 1000337331 Universitatsklinik Fur Innere Medizin Germany
 
004-3973978-0/1/1 27-Dec-2005 80LDQ 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
004-3974591-0/1/1 27-Dec-2005 80LDQ 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
004-3974591-0/1/2 27-Dec-2005 80LDQ 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
004-3974977-1/1/2 29-Dec-2005 80LDQ 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
DM9-5011639-0/2/1 21-Dec-2005 80LGX 3005445083 Olsen Industria E Comercio S.A. Brazil
 
442-1871381-4/1/1 27-Dec-2005 80LYY 3005431522 Betelcare Sdn Bhd Malaysia
 
XXX-0129671-5/1/2 06-Dec-2005 80MEG 3001137323 UNKNOWN Korea, Republic Of (South)
 
XXX-0133010-0/1/2 06-Dec-2005 80MEG 6353 Rymco Ltda Colombia
 
112-8609609-3/2/1 21-Dec-2005 80MEG 3003200511 Biotekne Srl Italy
 
XXX-0135962-0/1/4 28-Dec-2005 80MEG 3004110434 Bu Kwang Medical Inc. Korea, Republic Of (South)
 
XXX-0135970-3/1/4 28-Dec-2005 80MEG 3001027464 UNKNOWN Guatemala
 
FR1-0011372-4/2/1 05-Dec-2005 80MIA 3000247873 Nipro Corporation Japan
 
277-0108701-0/1/1 27-Dec-2005 80MMP 3004126958 Sino Disposable Industrial Co Hong Kong SAR
 
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