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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
BIP-0004354-9/1/1 04-May-2005 80FLL 3005097132 Exacon A/S Denmark
 
BIP-0004354-9/11/1 04-May-2005 80FLL 3005097132 Exacon A/S Denmark
 
G76-0077696-5/2/1 13-May-2005 80FMI 3002807200 F. Hoffmann-LaRoche Ltd. Switzerland
 
112-6432014-4/2/1 19-May-2005 80FMI 3004358329 B&C International Nv Belgium
 
112-6432014-4/6/1 19-May-2005 80FOR 3004358329 B&C International Nv Belgium
 
K51-0056857-2/21/1 18-May-2005 80FQM 3003075189 Rico International Trading Company Hong Kong SAR
 
322-2200601-0/1/1 11-May-2005 80FSA 3002806396 Arjo Med. AB United Kingdom
 
322-2200666-3/1/1 11-May-2005 80FSA 3002806396 Arjo Med. AB United Kingdom
 
AEK-6562453-4/1/1 27-May-2005 80KGX 3005141021 Nokia Oyj Finland
 
112-6296382-0/2/1 12-May-2005 80KME 3003768290 MED-I-PANT, INC. Canada
 
112-6296382-0/3/1 12-May-2005 80KME 3003768290 MED-I-PANT, INC. Canada
 
112-6383544-9/6/1 18-May-2005 80KXF 3004358329 B&C International Nv Belgium
 
EQ6-0004205-3/1/1 02-May-2005 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0004206-1/1/1 05-May-2005 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0004194-9/1/1 13-May-2005 80LDQ 3005092364 Perouse Plastie France
 
112-6432014-4/1/1 19-May-2005 80LDQ 3004358329 B&C International Nv Belgium
 
EQ6-0004242-6/1/1 24-May-2005 80LDQ 5833 EPPENDORF AG Germany
 
EM8-0005162-2/2/1 13-May-2005 80LGX 3002561207 Trident Medical Corp. Taiwan
 
EM8-0005174-7/2/1 24-May-2005 80LGX 3002561207 Trident Medical Corp. Taiwan
 
349-0872309-0/4/1 12-May-2005 80LYY 3003028381 Pt. Berlian Glovindo Indonesia
 
110-0474252-4/1/1 05-May-2005 80LYZ 3003896660 Shijiazhuang Wally Plastic Co., Ltd. China
 
110-0473977-7/1/1 14-May-2005 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
W69-1224262-6/1/1 17-May-2005 80LYZ 3004117953 Tongruhn Medical Products Co.,Ltd. China
 
508-0277401-3/1/1 03-May-2005 80LZA 3003564842 TOP GLOVE SDN BHD, Factories 2, 9 (HQ), 10 & 11 Malaysia
 
DE6-1201399-0/1/1 23-May-2005 80LZA 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
DE6-1201399-0/2/1 23-May-2005 80LZA 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
DE6-1201399-0/3/1 23-May-2005 80LZA 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
DE6-1201399-0/4/1 23-May-2005 80LZA 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
112-6542572-8/1/1 31-May-2005 80LZG 3004034924 Disetronic Medical Systems AG Switzerland
 
112-6519040-5/1/1 31-May-2005 80LZG 1000477110 Unomedical A/S Denmark
 
112-6383544-9/2/1 18-May-2005 80MQX 3004358329 B&C International Nv Belgium
 
112-6270888-6/1/3 05-May-2005 80MWV 3005019873 Sacb Mexico
 
112-6822417-7/1/1 11-May-2005 80MWV 3005099796 Minka Medical United Kingdom
 
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