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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 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7390111-9/1/1 28-May-2009 78FCE 3006664700 Medicina United Kingdom
 
DO7-8212102-7/1/1 13-May-2009 78FDF 3005783375 Ekona Gmbh Spol. S R.O. Czech Republic
 
H77-0114177-9/1/2 29-May-2009 78FFQ 3003238438 Technimen Skillers Pakistan
 
H77-0114177-9/1/11 29-May-2009 78FFQ 3003238438 Technimen Skillers Pakistan
 
396-0154374-5/1/3 07-May-2009 78FHQ 3003795590 A.L.M. Surgicare Pakistan
 
396-0154428-9/1/1 07-May-2009 78FHQ 3003707444 Sanex International Pakistan
 
BEA-9055062-1/1/3 20-May-2009 78FHQ 3007389672 FRANKO SHEHZAD SURGICO LTD. Pakistan
 
H77-0114177-9/1/12 29-May-2009 78FHQ 3003238438 Technimen Skillers Pakistan
 
FR1-0012668-4/2/1 13-May-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
UPS-4393095-5/1/1 01-May-2009 78FKX 1036337 Baxter Healthcare Corporation United States
 
UPS-4393095-5/2/1 15-May-2009 78FKX 1036337 Baxter Healthcare Corporation United States
 
JF7-0073931-7/1/1 29-May-2009 78GCF 3006680097 THD SpA Italy
 
DO7-8212102-7/1/2 13-May-2009 78MOA 3005783375 Ekona Gmbh Spol. S R.O. Czech Republic
 
336-6939168-5/1/1 05-May-2009 78MSD 1317056 Navilyst Medical, Inc United States
 
336-6939168-5/1/2 05-May-2009 78MSD 1317056 Navilyst Medical, Inc United States
 
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