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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
MH9-0089547-4/3/1 03-Feb-2011 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
112-0861938-2/1/1 28-Feb-2011 80FQZ 3008662807 Sika Dr Siebert & Kuhn Gmbh Germany
 
KX2-0044232-8/4/1 22-Feb-2011 80FRL 3006451935 Aid United International Co. Limited China
 
112-0451100-5/1/1 08-Feb-2011 80FRN 1000128388 Dai Wha Corporation, Ltd. Korea, Republic Of (South)
 
322-0415594-3/1/1 24-Feb-2011 80FSA 3002806396 Arjo Med. AB United Kingdom
 
112-0791277-0/1/1 16-Feb-2011 80KPE 3008755538 Maco Productions Spain
 
AL6-0048896-2/1/1 25-Feb-2011 80KPE 3008754377 Maco Pharma Spania Spain
 
XXX-0271649-7/1/1 22-Feb-2011 80KZH 3007331373 Laboratorios Rymco S.A. Colombia
 
XXX-0271649-7/1/2 22-Feb-2011 80KZH 3007331373 Laboratorios Rymco S.A. Colombia
 
UPS-1141418-8/1/1/A 10-Feb-2011 80LDQ 3008293333 Talika Marketing Hong Kong SAR
 
AEK-8642294-2/1/1 23-Feb-2011 80LDQ 3007481575 Yangzhou Tongfun Red International Trad China
 
112-9621305-4/1/1 23-Feb-2011 80LDQ 3006402425 Salts Healthcare United Kingdom
 
AEK-8642316-3/2/2 28-Feb-2011 80LDQ 3006388833 Soleko Spa/It Italy
 
EQ6-0012729-2/1/1 28-Feb-2011 80LDQ 5833 EPPENDORF AG Germany
 
231-0855894-5/1/1 22-Feb-2011 80LKB 3005670309 Budelpak Belgium
 
112-0970423-3/1/1 28-Feb-2011 80LMY 3008778543 Giant Biosensor Limited Hong Kong SAR
 
231-1067997-8/1/1 10-Feb-2011 80LYY 3005024094 Dipped Products (Thailand) Ltd. Thailand
 
525-0794540-1/1/1 07-Feb-2011 80LYZ 3008386557 Zibo Yinghao Medical Products Co., Ltd. China
 
E6T-1001239-0/2/1 09-Feb-2011 80LYZ 3003529075 Primus Gloves Pvt Limited India
 
UPS-2758916-0/17/1 10-Feb-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
UPS-2758571-3/3/1 10-Feb-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
TJE-1012025-1/1/1 11-Feb-2011 80LYZ 3008386557 Zibo Yinghao Medical Products Co., Ltd. China
 
E41-0067994-0/1/1 15-Feb-2011 80LYZ 3008467576 Shijiazhuang Star Plastic Co., Ltd China
 
TJE-1012099-6/1/1 18-Feb-2011 80LYZ 3008386557 Zibo Yinghao Medical Products Co., Ltd. China
 
BJV-0722278-0/1/2 22-Feb-2011 80LYZ 3003340718 Shijiazhuang Eversharp Plastic Products Co., Ltd. China
 
GL5-0223524-2/1/1 28-Feb-2011 80LYZ 3008191396 Zibo Intco Medical Products Company Limited China
 
112-0649108-1/1/1 16-Feb-2011 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-0649252-7/1/1 18-Feb-2011 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
DE6-3255197-9/21/1 28-Feb-2011 80LZA 3005099002 Great Glove Sdn Bhd Malaysia
 
112-9935422-8/1/1 23-Feb-2011 80MWV 3006776838 Nct Ltd T/A Medical Innovations United Kingdom
 
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