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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
112-7758164-5/2/1 07-Jan-2012 78EYQ 3008167192 Netti Avs Denmark
 
112-5278109-6/8/1 04-Jan-2012 78FAJ 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
112-9232302-3/3/1 06-Jan-2012 78FBK 3006992278 Surgimedik Healthcare India
 
112-5278109-6/1/1 04-Jan-2012 78FCL 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
112-5278109-6/5/1 04-Jan-2012 78FCR 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
112-5278109-6/7/1 04-Jan-2012 78FET 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
WC1-8458491-8/4/1 06-Jan-2012 78FHQ 3003032798 Diligent Medical Services Pakistan
 
WC1-8452844-4/63/1 06-Jan-2012 78FHQ 3003032798 Diligent Medical Services Pakistan
 
WC1-8452844-4/136/1 06-Jan-2012 78FHQ 1450901 Technicality Inc. United States
 
916-2183668-2/1/1 06-Jan-2012 78FHQ 3374 Hilbro (PVT) Ltd. Pakistan
 
FR1-0014243-4/1/1 19-Jan-2012 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0014209-5/1/1 17-Jan-2012 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-9232302-3/2/1 06-Jan-2012 78GBM 3006992278 Surgimedik Healthcare India
 
112-9900755-2/1/1 07-Jan-2012 78GBM 3007980894 Lilial France
 
112-5522373-2/3/1 20-Jan-2012 78KNW 2027467 Alphatec Spine, Inc. United States
 
112-8230011-4/1/1 07-Jan-2012 78LKY 3007335337 Ultramax Products United Kingdom
 
112-6866886-4/1/1 07-Jan-2012 78MRE 3008299451 Victor Labbate Md United States
 
112-5469627-6/1/1 31-Jan-2012 78MRE 3003269584 Coc Farmaceutici Srl Italy
 
112-9232302-3/1/1 06-Jan-2012 78MXQ 3006992278 Surgimedik Healthcare India
 
112-9232302-3/1/2 06-Jan-2012 78MXQ 3006992278 Surgimedik Healthcare India
 
UPS-4646683-1/1/1 27-Jan-2012 78MZS 3009231383 Vital Global Solution Sdn Bhd Malaysia
 
112-6284939-5/1/1 07-Jan-2012 78NHU 3008182617 Danamedic Aps Denmark
 
112-9232302-3/1/5 06-Jan-2012 78NMX 3006992278 Surgimedik Healthcare India
 
112-5278109-6/9/1 04-Jan-2012 78OCX 3006453991 Karl Storz GMBH & Co KG (KSVEM) Germany
 
112-9232302-3/1/7 06-Jan-2012 78OCY 3006992278 Surgimedik Healthcare India
 
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