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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
UPS-3151368-8/1/1 15-Sep-2011 80BWJ 3005923596 Pierenkemper Gmbh Germany
 
336-3295175-6/1/1 12-Sep-2011 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
336-3295175-6/1/2 12-Sep-2011 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
336-3295175-6/1/3 12-Sep-2011 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
336-3295175-6/1/4 12-Sep-2011 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
336-3295175-6/1/5 12-Sep-2011 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
112-8187972-0/1/3 09-Sep-2011 80FMF 3008447410 Batist S.R.O. Czech Republic
 
MH9-0096415-5/1/1 19-Sep-2011 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0095545-0/1/1 22-Sep-2011 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
112-8187972-0/3/5 09-Sep-2011 80FQM 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/4/1 09-Sep-2011 80FQM 3008447410 Batist S.R.O. Czech Republic
 
MH9-0095545-0/2/1 22-Sep-2011 80GCX 3004111085 Jiangsu Yuyue Medical Equipment & Supply Co. Ltd. China
 
112-8187972-0/3/2 09-Sep-2011 80KGX 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/1/2 09-Sep-2011 80KME 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/3/4 09-Sep-2011 80KXF 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/3/1 09-Sep-2011 80KXF 3008447410 Batist S.R.O. Czech Republic
 
112-3851365-4/1/1 26-Sep-2011 80KZE 3006126537 Flextronics International Austria
 
112-7982625-3/3/1 09-Sep-2011 80KZH 3007771384 Asap Endoscopic Pr Germany
 
112-2879992-5/1/1 30-Sep-2011 80KZH 3007028791 ALL PRO CORPORATION China
 
112-3366053-4/1/1 07-Sep-2011 80LDQ 3008644536 Heart Transverter Sa Costa Rica
 
112-7225195-4/1/2 07-Sep-2011 80LDQ 1282497 Covidien LLC United States
 
112-7225195-4/1/3 07-Sep-2011 80LDQ 2011068 Allergan Inc United States
 
112-7225195-4/1/4 07-Sep-2011 80LDQ 3007188933 Novasure United States
 
BOY-0002335-5/2/2 16-Sep-2011 80LDQ 3009050625 Wem Equipamentos Electronicos Lt Brazil
 
279-9738773-6/7/1 23-Sep-2011 80LDQ 3009048492 Min-Gen Enterprise Co., Ltd. China
 
EQ6-0013846-3/1/1 30-Sep-2011 80LDQ 5833 EPPENDORF AG Germany
 
112-8187972-0/5/2 09-Sep-2011 80LKB 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/5/1 09-Sep-2011 80LKB 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/6/1 09-Sep-2011 80LKB 3008447410 Batist S.R.O. Czech Republic
 
112-3501671-9/1/1 23-Sep-2011 80LLI 3000141834 Ultrassage Inc Canada
 
112-3686115-4/2/1 16-Sep-2011 80LYY 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
279-9739807-1/3/1 22-Sep-2011 80LYY 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
279-9739807-1/4/1 22-Sep-2011 80LYY 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
279-9739807-1/5/1 22-Sep-2011 80LYY 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
315-7352580-0/1/1 02-Sep-2011 80LYZ 3006113146 SUPER SAFE PLASTIC PRODUCTS CO., LTD. China
 
F23-9045740-6/1/1 07-Sep-2011 80LYZ 3008262374 Tangshan Pufa Plastic Products Co Ltd China
 
336-3295175-6/2/1 12-Sep-2011 80LZA 1000153304 Brightway Holdings SDN BHD Malaysia
 
W69-3201831-1/1/1/A 14-Sep-2011 80LZA 3003338735 JDA Plastic Rubber Co. Ltd. China
 
112-2752185-8/1/3 23-Sep-2011 80LZA 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2752185-8/1/1 23-Sep-2011 80LZC 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2752185-8/1/2 23-Sep-2011 80LZC 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2752185-8/1/4 23-Sep-2011 80LZC 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2752185-8/1/5 23-Sep-2011 80LZC 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2752185-8/1/6 23-Sep-2011 80LZC 1000254914 Zhangjiagang Dayu Rubber Products Co., Ltd. China
 
112-2904354-7/1/1 16-Sep-2011 80LZH 3004146070 Caesarea Medical Electronics Ltd. Israel
 
112-8187972-0/1/4 09-Sep-2011 80MMP 3008447410 Batist S.R.O. Czech Republic
 
UPS-6183545-3/1/1 15-Sep-2011 80MMS 3008351737 Bodywise Ltd United Kingdom
 
UPS-3100109-8/1/1/A 19-Sep-2011 80MQX 3004472232 Schwa-Medico Germany
 
UPS-3100109-8/1/1/B 19-Sep-2011 80MQX 3004472232 Schwa-Medico Germany
 
112-8187972-0/3/3 09-Sep-2011 80MXI 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/3/6 09-Sep-2011 80MXI 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/3/7 09-Sep-2011 80MXI 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/3/8 09-Sep-2011 80MXI 3008447410 Batist S.R.O. Czech Republic
 
112-8187972-0/8/1 09-Sep-2011 80MXI 3008447410 Batist S.R.O. Czech Republic
 
112-3686115-4/1/1 16-Sep-2011 80NPC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-3686115-4/1/4 16-Sep-2011 80NPC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-3686115-4/1/3 16-Sep-2011 80NPC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-3686115-4/1/2 16-Sep-2011 80NPC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
112-2924365-9/1/2 12-Sep-2011 80OUK 3008996973 Safetec Healthcare India
 
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