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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
NS1-0006932-8/1/1 02-Mar-2011 80FLE 3005343391 Tuttnauer Co., Ltd Israel
 
MH9-0090272-6/1/1 25-Mar-2011 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0090272-6/1/3 25-Mar-2011 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
BJV-0233399-6/1/1 07-Mar-2011 80FQM 3004710519 Convertors De Mexico Mexico
 
FR1-0013729-3/3/1 04-Mar-2011 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FY6-2007956-3/7/1 11-Mar-2011 80KCT 3007420666 Sultan Healthcare United States
 
UPS-1290680-2/1/1 25-Mar-2011 80KGX 3004120371 Changzhou Hualian Health Dressing Co Ltd China
 
XXX-0174340-1/1/1 07-Mar-2011 80KYS 3008531835 Donglee Industrial Co., Ltd. China
 
XXX-0174340-1/2/2 07-Mar-2011 80KYS 3008531835 Donglee Industrial Co., Ltd. China
 
109-0826372-5/3/1 21-Mar-2011 80KZH 3007282863 Bd Singapore
 
MH9-0090272-6/1/2 25-Mar-2011 80LBI 3003307657 Ningbo David Medical Device Co.,Ltd China
 
BQQ-0003505-8/271/1 04-Mar-2011 80LDQ 3008413425 Sarepta Mediplast Ukraine
 
112-5802283-3/1/1 16-Mar-2011 80LDQ 3002673652 NDD Medizitechnik AG Switzerland
 
WC4-7003659-9/1/1/H 02-Mar-2011 80LYY 3004150701 SHANDONG BLUE SAIL INNOVATION CO LTD China
 
002-1180990-0/1/1 01-Mar-2011 80LYZ 3003116612 Shijiazhuang Great Vision Plastic Products Co., Ltd. China
 
WC4-7003659-9/1/1/E 02-Mar-2011 80LYZ 3005800001 Firstar Health Care Company China
 
WC4-7003659-9/1/1/F 02-Mar-2011 80LYZ 3005800001 Firstar Health Care Company China
 
WC4-7003659-9/1/1/G 02-Mar-2011 80LYZ 3005800001 Firstar Health Care Company China
 
UPS-5646151-3/21/1 18-Mar-2011 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
W69-3182507-0/1/1 21-Mar-2011 80LYZ 3008729422 Zibo Yingjie Medical Products Co., Ltd. China
 
E41-0068618-4/1/1 22-Mar-2011 80LYZ 3006802900 Shijiazhuang Brethern Plastic Co.,Ltd China
 
525-0796083-0/1/1 29-Mar-2011 80LYZ 3008386557 Zibo Yinghao Medical Products Co., Ltd. China
 
442-1552653-2/1/7 31-Mar-2011 80LYZ 7912 AM Gloves Co Ltd Taiwan
 
442-1552653-2/1/8 31-Mar-2011 80LYZ 7912 AM Gloves Co Ltd Taiwan
 
442-1552653-2/1/9 31-Mar-2011 80LYZ 7912 AM Gloves Co Ltd Taiwan
 
J86-0867262-4/3/1 09-Mar-2011 80LZA 3000239897 Pt. Maja Agung Latexindo Indonesia
 
NS1-0006932-8/1/3 02-Mar-2011 80MED 3005343391 Tuttnauer Co., Ltd Israel
 
NS1-0006932-8/1/2 02-Mar-2011 80MED 3005343391 Tuttnauer Co., Ltd Israel
 
DO7-8378325-4/1/1 22-Mar-2011 80MQX 3008793494 Cao Bao Yuan China
 
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