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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
FR1-0011668-5/1/2 07-Aug-2007 78FAQ 3003279193 Amsino Medical Instrument Co Ltd China
 
110-8387740-1/1/1 02-Aug-2007 78FBP 3003790304 Gyrus Acmi, Incorporated United States
 
BQL-0012713-2/24/1 20-Aug-2007 78FCE 3005918755 Globus, Ooo Russia
 
110-9253317-7/1/1 14-Aug-2007 78FDT 1000549845 Olympus Corp United States
 
AEK-7195186-3/1/1 20-Aug-2007 78FHW 3003795590 A.L.M. Surgicare Pakistan
 
FR1-0011912-7/3/1 07-Aug-2007 78FJI 3000247873 Nipro Corporation Japan
 
XXX-0245299-4/1/4 07-Aug-2007 78GBM 3010 Meditec S.A. Colombia
 
993-0064656-1/4/7 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064651-2/4/6 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064646-2/2/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064646-2/2/2 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064644-7/3/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064644-7/3/3 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064645-4/3/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064645-4/3/2 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064647-0/3/4 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064647-0/3/3 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064655-3/3/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064659-5/4/4 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0061474-2/3/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0061474-2/3/2 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
993-0064652-0/9/1 28-Aug-2007 78GCJ 3001436772 Davol Surgical Innovations S.A. de C.V. Mexico
 
T94-0046031-5/3/1 23-Aug-2007 78KNT 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
112-7662394-1/1/1 24-Aug-2007 78MRE 3003265951 Paladin Labs Inc Canada
 
T94-0046031-5/7/1 23-Aug-2007 78NWR 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
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