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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
BJV-0243916-5/2/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/78/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/52/2 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/23 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/6 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/81/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/7 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/9 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/9 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/57/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/8 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/18/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/78/2 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/6/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/80/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/7 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/15/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/7 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/9 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/80/6 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/45/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/4/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/6 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/17/1 31-Aug-2011 78FDE 3004710519 Convertors De Mexico Mexico
 
112-3362083-5/1/2 24-Aug-2011 78FDX 3009075481 Changzhou Lookmed Medical Instrument Co., LTD China
 
853-0525565-6/20/1 01-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525573-0/21/1 01-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/18/1 01-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527226-3/22/1 05-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527235-4/26/1 05-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527235-4/24/1 05-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523857-9/13/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523866-0/8/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523866-0/9/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523866-0/12/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/17/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/9/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/17/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525545-8/9/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525545-8/10/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/21/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/17/1 09-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527255-2/25/1 19-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527247-9/17/1 22-Aug-2011 78FFA 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
UPS-5159563-8/1/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/11/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/8/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/5/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/10/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/14/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/12/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/2/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/13/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/7/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/6/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/3/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/9/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
UPS-5159563-8/4/1 04-Aug-2011 78FGE 3002806735 Cordis Europa Nv Netherlands
 
004-5998192-4/2/1 10-Aug-2011 78FGE 1000220862 Micro Therapeutics Inc, Dba Ev3 Neurovascular United States
 
004-5998192-4/6/1/A 10-Aug-2011 78FGE 2183870 Ev3, Inc. United States
 
004-5998192-4/6/1/C 10-Aug-2011 78FGE 2183870 Ev3, Inc. United States
 
004-5998192-4/7/1 10-Aug-2011 78FGE 2183870 Ev3, Inc. United States
 
004-5998192-4/9/1 10-Aug-2011 78FGE 2183870 Ev3, Inc. United States
 
004-5998192-4/13/1 10-Aug-2011 78FGE 2183870 Ev3, Inc. United States
 
BJV-0241058-8/84/1 10-Aug-2011 78FGM 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242206-2/57/1 10-Aug-2011 78FGM 3002834291 Mian Shahid Corporation Pakistan
 
234-0130064-7/1/2 05-Aug-2011 78FHQ 3008981666 Clinical Surgical Pakistan
 
234-0130064-7/1/1 05-Aug-2011 78FHQ 3008981666 Clinical Surgical Pakistan
 
112-7680633-2/1/6 05-Aug-2011 78FHQ 6750 Paul Instruments (India) India
 
BJV-0240971-3/73/3 10-Aug-2011 78FHQ 3003145254 Everlast Surgical Company Pakistan
 
BJV-0240975-4/53/1 10-Aug-2011 78FHQ 3003145254 Everlast Surgical Company Pakistan
 
BJV-0241005-9/59/1 10-Aug-2011 78FHQ 3003145254 Everlast Surgical Company Pakistan
 
BJV-0242763-2/29/9 10-Aug-2011 78FHQ 3002807679 Mamoash Impex Pakistan
 
BJV-0242771-5/75/2 10-Aug-2011 78FHQ 3002807679 Mamoash Impex Pakistan
 
523-0941819-3/7/1 30-Aug-2011 78FHQ 3009058024 Rebstock Instruments Germany
 
853-0525565-6/19/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525565-6/18/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525573-0/25/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525573-0/23/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525573-0/24/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525573-0/22/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/23/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/19/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/20/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/22/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/24/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527206-5/21/1 01-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527214-9/25/1 05-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527214-9/24/1 05-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527226-3/17/1 05-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527226-3/16/1 05-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0523857-9/16/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/13/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/12/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/11/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525457-6/10/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/14/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/12/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/15/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/16/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/13/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/19/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/20/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/18/1 09-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527255-2/29/1 19-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527255-2/27/1 19-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527255-2/26/1 19-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527255-2/28/1 19-Aug-2011 78FPD 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
112-0093283-3/2/1 24-Aug-2011 78GCQ 3007222774 Olympus Corporatio Japan
 
112-0093283-3/1/1 24-Aug-2011 78GCQ 3007222774 Olympus Corporatio Japan
 
M21-0744253-7/8/1 26-Aug-2011 78KDH 3009055989 Medica D Sa De Cv Mexico
 
112-6361484-8/1/1 05-Aug-2011 78LKY 3005401991 Danamedic Aps Denmark
 
112-6285072-4/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6285152-4/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360187-8/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6361371-7/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360266-0/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6334524-5/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6361190-1/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6333915-6/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6360375-9/1/1 05-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
112-6727429-2/1/1 08-Aug-2011 78NHU 3008182617 Danamedic Aps Denmark
 
BJY-0709124-0/3/7 18-Aug-2011 78NWU 3005657189 Purple Surgical International United Kingdom
 
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