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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
112-9342123-0/1/1 26-Apr-2012 80FMG 3004595684 Trokamed GmbH Germany
 
MH9-0101104-8/1/1 19-Apr-2012 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0102260-7/1/1 20-Apr-2012 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
XXX-0177731-8/1/2 27-Apr-2012 80FNJ 1000244108 Unknown China
 
XXX-0177731-8/1/3 27-Apr-2012 80FNJ 1000244108 Unknown China
 
XXX-0177731-8/1/4 27-Apr-2012 80FNJ 1000244108 Unknown China
 
XXX-0177731-8/1/1 27-Apr-2012 80FNJ 1000244108 Unknown China
 
FR1-0014326-7/1/1 06-Apr-2012 80FOZ 3004070915 Hanako Medical Japan
 
BJE-0118659-3/2/1 06-Apr-2012 80FPA 3002999813 Hospira Costa Rica Ltda Costa Rica
 
BFV-0430728-6/1/1 23-Apr-2012 80FPF 3007940403 Valentine International Ltd China
 
KR3-0112056-3/2/1/B 06-Apr-2012 80FQM 3004574016 Laboratorios Le Roy Mexico
 
224-4182054-9/1/5 12-Apr-2012 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
224-4182054-9/1/3 12-Apr-2012 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
224-4182054-9/1/2 12-Apr-2012 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
224-4182054-9/1/1 12-Apr-2012 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
224-4182054-9/1/4 12-Apr-2012 80FQM 3007028032 YONGKANG BANGLI MEDICAL PRODUCTS CO., LTD China
 
BJE-0118659-3/1/1 06-Apr-2012 80FRN 3002999813 Hospira Costa Rica Ltda Costa Rica
 
BJE-0118779-9/1/1 06-Apr-2012 80FRN 3002999813 Hospira Costa Rica Ltda Costa Rica
 
FR1-0014270-7/1/1 06-Apr-2012 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
FR1-0014355-6/4/1 16-Apr-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
UPS-6012514-9/1/1 27-Apr-2012 80FRN 3005059744 Karolinska Univ Sj Sweden
 
ANQ-2012175-2/1/18 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/2 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/3 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/28 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/21 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/7 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/6 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/5 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/4 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/29 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/24 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/8 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2012175-2/1/1 19-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/18 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/17 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/3 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/2 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/1 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2011987-1/1/10 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2010465-9/1/1 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2010465-9/1/19 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2010465-9/1/4 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
ANQ-2010465-9/1/15 20-Apr-2012 80JOK 3002807418 K T Surgico (PVT) Ltd. Pakistan
 
112-6754088-3/1/1 23-Apr-2012 80KCT 3002808930 Nelipak Thermoforming Bv Netherlands
 
BMW-0032776-1/4/1 03-Apr-2012 80KGX 3004031006 Waton Foundation Hong Kong SAR
 
BMW-0032776-1/4/2 03-Apr-2012 80KGX 3004031006 Waton Foundation Hong Kong SAR
 
ARV-2811152-9/1/1 06-Apr-2012 80KGX 3005083505 ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD., China
 
XXX-0281671-9/1/4 02-Apr-2012 80KZH 3000247873 Nipro Corporation Japan
 
EQ6-0014772-0/1/1 25-Apr-2012 80LDQ 5833 EPPENDORF AG Germany
 
UPS-6711824-3/2/1 02-Apr-2012 80LKB 3004939558 Planet (Hong Kong) International Co., Ltd. Hong Kong SAR
 
UPS-6694269-2/4/1 03-Apr-2012 80LKB 3006343670 Planet Hk China
 
WC1-8487983-9/13/1 03-Apr-2012 80LYY 3002327142 Zhenjiang Kangda Emulsion Co,Ltd China
 
004-6269051-2/22/1 13-Apr-2012 80LYY 3009444107 Sea Dragon De Maxico S De R.L. De Mexico
 
115-0079166-7/2/1/B 06-Apr-2012 80LYZ 3008177916 Tangshan Hongyun Plastic Products Co., Ltd China
 
916-2297101-7/1/1 18-Apr-2012 80LYZ 3007559292 Zibo Litong Plastic Products Co Ltd China
 
916-2297101-7/2/1 18-Apr-2012 80LYZ 3007559292 Zibo Litong Plastic Products Co Ltd China
 
916-2297101-7/3/1 18-Apr-2012 80LYZ 3007559292 Zibo Litong Plastic Products Co Ltd China
 
D52-0949194-8/1/1 19-Apr-2012 80LYZ 3008754768 YONGSHENG PLASTIC CO LTD China
 
D52-0949194-8/1/2 19-Apr-2012 80LYZ 3008754768 YONGSHENG PLASTIC CO LTD China
 
D52-0949194-8/1/3 19-Apr-2012 80LYZ 3008754768 YONGSHENG PLASTIC CO LTD China
 
D52-0949194-8/1/4 19-Apr-2012 80LYZ 3008754768 YONGSHENG PLASTIC CO LTD China
 
WBA-2051975-6/2/1 30-Apr-2012 80LYZ 3002808781 Shanghai Pm Plastic Enterprise Co., Ltd. China
 
HG8-0136536-9/1/1 16-Apr-2012 80MDR 3005732376 Sturdy Industrial Co Ltd Taiwan
 
112-6337215-8/1/1 13-Apr-2012 80MEG 3003130765 Changzhou Jintian General Merchandise Co.,Ltd. China
 
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