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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
336-6525288-2/4/1 21-Aug-2012 80BRZ 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
M76-7345370-2/1/1 28-Aug-2012 80BWJ 3005923596 Pierenkemper Gmbh Germany
 
BJY-0710331-8/3/1 03-Aug-2012 80FLN 3009670023 Medi Care Group S.A. De C.V. Mexico
 
112-8409163-9/1/1 03-Aug-2012 80FMF 3008822460 Shiva Products India
 
112-8704280-3/1/1 27-Aug-2012 80FMF 3009663347 Sunwell Biotech Co Ltd China
 
T94-0058004-7/36/1 16-Aug-2012 80FMI 3006243109 Mgb Endoskopische Gerate Gmbh Germany
 
T94-0058004-7/40/1 16-Aug-2012 80FMI 3006243109 Mgb Endoskopische Gerate Gmbh Germany
 
D99-1027390-0/1/1 07-Aug-2012 80FMP 3009638795 Ortoiberica S.L. Spain
 
MH9-2003174-6/1/1 09-Aug-2012 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
BJY-0710340-9/2/1 03-Aug-2012 80FMZ 3009670593 Arroba Ingenieria Sa De Cv Mexico
 
BJY-0710340-9/1/1 03-Aug-2012 80FMZ 3009670593 Arroba Ingenieria Sa De Cv Mexico
 
BJY-0710319-3/1/1 03-Aug-2012 80FMZ 3009679471 Olidef Cz Industria Comercio Apar Hospitalares Ltda Brazil
 
AZW-0062691-5/1/1 02-Aug-2012 80FNL 3004185892 Hill Rom SAS France
 
BJY-0710200-5/1/1 21-Aug-2012 80FNL 3007834672 Hospimetal Ind Metal Equip Brazil
 
FR1-0014535-3/2/1 06-Aug-2012 80FOZ 3004070915 Hanako Medical Japan
 
EDX-0009765-9/1/1 21-Aug-2012 80FOZ 3009462102 Quindao Carefully International Trade China
 
336-6510879-5/1/1 06-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
112-7556875-1/1/1/B 07-Aug-2012 80FPA 3002862267 Dr J Hansler Germany
 
112-7556875-1/1/1/C 07-Aug-2012 80FPA 3002862267 Dr J Hansler Germany
 
112-7556875-1/1/1/D 07-Aug-2012 80FPA 3001570557 Terumo Europe Belgium
 
112-7556875-1/1/1/E 07-Aug-2012 80FPA 3003427993 Transcojet Germany
 
336-6510879-5/2/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6510879-5/4/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6510879-5/5/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6525288-2/2/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6525288-2/1/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6525288-2/7/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6525288-2/3/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
336-6525288-2/5/1 21-Aug-2012 80FPA 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
N59-0195993-6/1/1 28-Aug-2012 80FPA 3004102031 Terumo Medical Products Hangzhou Co., Ltd. China
 
N59-0195993-6/2/1 28-Aug-2012 80FPA 3004102031 Terumo Medical Products Hangzhou Co., Ltd. China
 
BJY-0710344-1/1/1 06-Aug-2012 80FPL 3000315977 Fanem Ltda Brazil
 
XXX-0178624-4/3/1 30-Aug-2012 80FQM 3009213313 Fajas Salome Colombia
 
791-2898371-9/9/2 22-Aug-2012 80FRI 3006667511 Seca Gmbh And Co Kg Germany
 
791-2898371-9/10/1 22-Aug-2012 80FRI 3006667511 Seca Gmbh And Co Kg Germany
 
BJY-0710311-0/3/1 03-Aug-2012 80FRK 3009674567 Wem Equipamentos Electronicos Ltda Brazil
 
FR1-0014402-6/3/1 21-Aug-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
791-2898371-9/13/1 22-Aug-2012 80FRW 3006667511 Seca Gmbh And Co Kg Germany
 
UPS-4263199-8/10/1 27-Aug-2012 80KGX 3005052406 Chain Medical Products Co., Ltd. China
 
BJY-0710344-1/1/3 06-Aug-2012 80LBI 3000315977 Fanem Ltda Brazil
 
112-7959412-6/1/1 09-Aug-2012 80LDH 3005174015 Brial Allergen Gmb Germany
 
EQ6-0015123-5/1/1 01-Aug-2012 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0015271-2/1/1 03-Aug-2012 80LDQ 5833 EPPENDORF AG Germany
 
BJY-0710335-9/4/1 03-Aug-2012 80LLK 3009670418 Degasa Sa De Cv Mexico
 
AP4-0052831-5/1/1 02-Aug-2012 80LYY 3002808247 Sri Johani Sdn Bhd Malaysia
 
MC2-6322007-1/1/1 02-Aug-2012 80LYZ 3009227458 Hebei Tengda Plastic Co.,Ltd China
 
MC2-6327440-9/1/1 13-Aug-2012 80LYZ 3009227458 Hebei Tengda Plastic Co.,Ltd China
 
EJK-0031072-3/1/1 09-Aug-2012 80LZC 1000266564 Siam Sempermed Corp Ltd Thailand
 
EJK-0031072-3/1/2 09-Aug-2012 80LZC 1000266564 Siam Sempermed Corp Ltd Thailand
 
EJK-0033194-3/1/1 22-Aug-2012 80LZC 3003069816 SGMP Company Limited Thailand
 
EJK-0033194-3/1/2 22-Aug-2012 80LZC 3003069816 SGMP Company Limited Thailand
 
791-2898371-9/8/1 22-Aug-2012 80MRL 3006667511 Seca Gmbh And Co Kg Germany
 
791-2898371-9/11/1 22-Aug-2012 80MRL 3006667511 Seca Gmbh And Co Kg Germany
 
791-2898371-9/9/1 22-Aug-2012 80MRL 3006667511 Seca Gmbh And Co Kg Germany
 
336-6525288-2/6/1 21-Aug-2012 80NEP 3002806588 Baxter Productos Medicos Ltda. Costa Rica
 
BJY-0710344-1/2/1 06-Aug-2012 80NZG 3000315977 Fanem Ltda Brazil
 
AZW-0062103-1/1/1 01-Aug-2012 80NZJ 3004985499 Newport Medical Inst United States
 
BJY-0710331-8/1/2 03-Aug-2012 80ONM 3009670023 Medi Care Group S.A. De C.V. Mexico
 
BJY-0710344-1/1/2 06-Aug-2012 80ONM 3000315977 Fanem Ltda Brazil
 
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