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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
FR1-0013429-0/1/1 08-Sep-2010 80BRZ 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
231-8658384-8/1/2 09-Sep-2010 80FLL 3003010579 Onbo Electronic (Shenzhen) Co., Ltd China
 
231-8658384-8/1/3 09-Sep-2010 80FLL 3003010579 Onbo Electronic (Shenzhen) Co., Ltd China
 
100-7011113-2/7/1 17-Sep-2010 80FNS 3007817017 AAKK SURGICAL CORPORATION Pakistan
 
100-7011113-2/7/2 17-Sep-2010 80FNS 3007817017 AAKK SURGICAL CORPORATION Pakistan
 
100-7011113-2/8/1 17-Sep-2010 80FNS 3007817017 AAKK SURGICAL CORPORATION Pakistan
 
FV4-5031128-0/26/1 23-Sep-2010 80FQM 3008456203 Trafalgar First Aid Australia
 
905-0924037-1/3/1 23-Sep-2010 80GCX 3006236525 Omnia Spa Italy
 
BJY-0707789-2/3/5 02-Sep-2010 80JOK 3005657189 Purple Surgical International United Kingdom
 
BAO-0013928-7/1/20 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/21 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/22 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/23 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/24 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/25 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/26 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/27 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/28 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/35 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
BAO-0013928-7/1/36 22-Sep-2010 80KYS 3008431878 Shering Plough United States
 
EQ6-0011636-0/1/1 08-Sep-2010 80LDQ 3008508987 Phywe Systeme Gmbh Germany
 
EQ6-0011775-6/1/1 22-Sep-2010 80LDQ 5833 EPPENDORF AG Germany
 
E6T-1000963-6/1/1/B 28-Sep-2010 80LYY 3363 Perusahaan Pelindung Getah Malaysia
 
D52-0939901-8/1/1 03-Sep-2010 80LYZ 3008309371 Shandong Huayue Glov Co Ltd China
 
TJE-1006079-6/1/1 03-Sep-2010 80LYZ 3008178183 Zibo Boxiang Plastic And Rubber Co., Ltd. China
 
JJ8-0287394-0/1/2 07-Sep-2010 80LYZ 3008313016 Wuxi Shenzhou Plastic Products Company China
 
JJ8-0287394-0/3/1 07-Sep-2010 80LYZ 3008313016 Wuxi Shenzhou Plastic Products Company China
 
E41-0066976-8/1/1/A 09-Sep-2010 80LYZ 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
E41-0066976-8/1/1/B 09-Sep-2010 80LYZ 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
E41-0066976-8/1/1/C 09-Sep-2010 80LYZ 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
E41-0066976-8/1/1/D 09-Sep-2010 80LYZ 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
EJK-0003459-6/1/1 24-Sep-2010 80LYZ 3008467576 Shijiazhuang Star Plastic Co., Ltd China
 
EJK-0003707-8/1/1 24-Sep-2010 80LYZ 3008467576 Shijiazhuang Star Plastic Co., Ltd China
 
EJK-0001444-0/1/1 25-Sep-2010 80LYZ 3007773259 SHIJIAZHUANG CENTURY PLASTIC CO., LTD. China
 
E6T-1000903-2/1/1/A 28-Sep-2010 80LZA 3006196100 Pt Mahakarya Inti Buana Indonesia
 
E41-0066976-8/1/1/E 09-Sep-2010 80LZC 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
E41-0066976-8/1/1/F 09-Sep-2010 80LZC 3008395134 Shijiazhuang Universal Channel Plastic Co., Ltd China
 
EDX-0008953-2/1/1 15-Sep-2010 80MED 3008463328 Maqa C.A. Venezuela
 
112-8014604-7/1/1 16-Sep-2010 80MQX 3004591155 Agoart Snc Italy
 
112-7432429-6/1/1 03-Sep-2010 80MSN 3008360514 Shenzhen Ahk Technology Co., China
 
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