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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
W69-1233062-9/12/1 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1233815-0/15/1 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1233815-0/15/2 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/2/6 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/2/7 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/2/8 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/2/9 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/2/10 19-Oct-2005 80BYY 3003782560 Changshu Medical Appliance Factory China
 
110-2525924-6/2/4 12-Oct-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
110-2525924-6/2/7 12-Oct-2005 80FLL 3002807626 Covidien, formerly MMJ S.A de C.V. Mexico
 
004-3972138-2/1/1 18-Oct-2005 80FMF 3005194448 Interwind Ltd Switzerland
 
110-2383619-4/1/1/V 24-Oct-2005 80FMF 1118880 Terumo Medical Corporation United States
 
606-0088748-7/18/1 14-Oct-2005 80FQM 3005167670 Profit International Enterprises Ltd Hong Kong SAR
 
AKJ-0006991-8/1/9/B 19-Oct-2005 80FQM 3004434112 Galafarm Ukraine
 
EM8-0005452-7/1/1 06-Oct-2005 80FRN 1000128388 Dai Wha Corporation, Ltd. Korea, Republic Of (South)
 
W69-1239076-3/1/2 19-Oct-2005 80JOL 3003782560 Changshu Medical Appliance Factory China
 
W69-1239076-3/1/3 19-Oct-2005 80JOL 3003782560 Changshu Medical Appliance Factory China
 
BMC-0400040-9/10/1 05-Oct-2005 80KGX 3005096486 Ezra Zabez International Company Limited China
 
W66-0019569-8/1/1 15-Oct-2005 80KYS 3004648164 Sound Medical Corp. Taiwan
 
XXX-0127252-6/1/3 11-Oct-2005 80KYZ 3005305163 Cecilia Medina Luna Guatemala
 
XXX-0129269-8/1/14 11-Oct-2005 80KYZ 3003910417 Becton Dickinson Ind. Cirurgicas Ltda. Brazil
 
W69-1232476-2/5/1 15-Oct-2005 80KYZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
W69-1232476-2/10/1 15-Oct-2005 80KYZ 1000471634 Changchun Kangda Medical Supply Co Ltd China
 
W69-1232476-2/10/2 15-Oct-2005 80KYZ 1000471634 Changchun Kangda Medical Supply Co Ltd China
 
W69-1233062-9/3/1 19-Oct-2005 80KYZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
112-7906716-8/1/1 31-Oct-2005 80KZH 1000366600 Becton Dickinson Germany
 
EQ6-0004529-6/1/1 07-Oct-2005 80LDQ 5833 EPPENDORF AG Germany
 
004-3971963-4/1/1 17-Oct-2005 80LDQ 3005171252 Cbm Srl Officine Metalmeccaniche Italy
 
EQ6-0004580-9/1/1 17-Oct-2005 80LDQ 1000547013 Weldon Industries (Pvt) Ltd. Pakistan
 
EQ6-0004596-5/1/1 20-Oct-2005 80LDQ 5833 EPPENDORF AG Germany
 
231-1203595-4/1/1 12-Oct-2005 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1203595-4/1/2 12-Oct-2005 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1203595-4/1/3 12-Oct-2005 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
990-0890667-1/1/1 31-Oct-2005 80LYZ 3001204057 Shanghai Poseidon Plastic Product Co Ltd China
 
XXX-0128080-0/1/1/D 11-Oct-2005 80MEG 1118880 Terumo Medical Corporation United States
 
XXX-0128373-9/1/4 11-Oct-2005 80MEG 3001193222 Sung Shin Trading Co Korea, Republic Of (South)
 
XXX-0129144-3/1/1 11-Oct-2005 80MEG 3005321232 Ingrid Vasquez Guatemala
 
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