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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
112-1232484-4/1/1 02-May-2006 80FLL 2917293 Genentech, Inc. United States
 
112-1232484-4/2/1 02-May-2006 80FLL 3002807200 F. Hoffmann-LaRoche Ltd. Switzerland
 
424-0148101-7/53/1 08-May-2006 80FME 3003386367 Icat, Sa De Cv El Salvador
 
872-0125884-2/2/3 17-May-2006 80FME 3004122598 Productos Medline, S.A. de C.V. Mexico
 
AEK-7096524-5/15/1 11-May-2006 80FMF 3004723151 Legaay International Netherlands
 
872-0125884-2/1/1 17-May-2006 80FMF 3004122598 Productos Medline, S.A. de C.V. Mexico
 
110-4453517-1/1/1 12-May-2006 80FMI 3003437923 Pyng Medical Corporation Canada
 
XXX-0133844-2/2/1 30-May-2006 80FMI 3000198132 Samkwang Industrial Corporation Korea, Republic Of (South)
 
AEK-7096524-5/10/3 11-May-2006 80FMQ 3004723151 Legaay International Netherlands
 
WA5-0003277-8/1/1 03-May-2006 80FMZ 3005611285 K Systems Denmark
 
MH9-0051062-8/1/1 24-May-2006 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
D53-0611183-7/1/1 13-May-2006 80FNK 3005353654 Golden Season Pte. Ltd. Singapore
 
ANP-0004228-4/1/1 12-May-2006 80FQM 3004606451 Dae Seung Co., Ltd. Korea, Republic Of (South)
 
ANP-0004228-4/2/1 12-May-2006 80FQM 3004606451 Dae Seung Co., Ltd. Korea, Republic Of (South)
 
112-1267656-5/1/1 22-May-2006 80FRL 3004806428 Kenrico LTD Japan
 
G43-0068853-3/2/1 01-May-2006 80FRN 3004571392 Jms Co., Ltd. Japan
 
100-0694167-7/1/1 01-May-2006 80KGX 3005463878 Ion Farms Co Korea, Republic Of (South)
 
AEK-7098167-1/4/3 05-May-2006 80KZH 3005622604 Mubarik Impex Pakistan
 
GL8-0014497-1/2/1/A 01-May-2006 80LDQ 2014730 Hudson Respiratory Care Inc United States
 
GL8-0014497-1/8/1 01-May-2006 80LDQ 2014730 Hudson Respiratory Care Inc United States
 
GL8-0014526-7/5/1 01-May-2006 80LDQ 3004365956 Teleflex Medical Mexico
 
U33-0013538-1/2/4 04-May-2006 80LDQ 3002808508 Wu Ho Medical Instruments Taiwan
 
EQ6-0004947-0/1/1 05-May-2006 80LDQ 5833 EPPENDORF AG Germany
 
EG6-1183730-3/1/1 10-May-2006 80LDQ 3004899131 Clearpoint International Direct Marketing Inc. Canada
 
112-1286796-6/1/1 11-May-2006 80LDQ 1000205351 Honda Electronics Co Ltd Japan
 
MC2-0045349-6/1/1 12-May-2006 80LDQ 3004205551 Guangdong Institude Of Ultrasonic Instruments Co Ltd Hong Kong SAR
 
112-1597503-0/1/1/C 30-May-2006 80LDQ 3001281578 Laboratories P.B.E. France
 
EQ6-0005102-1/1/1 30-May-2006 80LDQ 5833 EPPENDORF AG Germany
 
615-0260001-0/1/2 02-May-2006 80LYY 3002808366 TG Medical Sdn Bhd (Factory 3) Malaysia
 
110-0507913-3/2/1 02-May-2006 80LYY 3002808366 TG Medical Sdn Bhd (Factory 3) Malaysia
 
231-3186453-2/1/1 04-May-2006 80LYY 3003635929 KI-Kepong Rubber Products Sdn Bhd Malaysia
 
110-9028697-2/1/1 05-May-2006 80LYY 3005430650 Pt. Mandiri Inti Buana Indonesia
 
110-0508616-1/1/1 09-May-2006 80LYY 3002808366 TG Medical Sdn Bhd (Factory 3) Malaysia
 
110-0508616-1/2/1 09-May-2006 80LYY 3002808366 TG Medical Sdn Bhd (Factory 3) Malaysia
 
231-3187469-7/1/1 04-May-2006 80LYZ 3004532785 Shijiazhuang Brilliant Ocean Plastic Co., Ltd. China
 
EE6-2012997-7/1/1 11-May-2006 80MEA 1000162947 Jms Co., Ltd. Japan
 
551-4245015-9/27/1/B 04-May-2006 80MEC 3005632303 Unknown Taiwan
 
551-4245015-9/27/1/C 04-May-2006 80MED 3005632303 Unknown Taiwan
 
FR1-0011451-6/1/1 02-May-2006 80MIA 3000247873 Nipro Corporation Japan
 
FR1-0011474-8/1/1 19-May-2006 80MIA 3000247873 Nipro Corporation Japan
 
112-1422399-4/1/1 15-May-2006 80MMS 3005017924 Glycobiosciences Inc Canada
 
DQ7-7008594-1/11/1 03-May-2006 80MQX 3003610489 Oasis Trading Korea, Republic Of (South)
 
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