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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 85-Obstetrical & Gynecological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2864563-1/1/10 29-Aug-2011 85HDF 3008684204 Faizan Surgical Pakistan
 
UPS-3291344-0/1/1 24-Aug-2011 85HEX 3009082822 Soft Imaging & Medical Solutions India
 
BJV-0242734-3/85/7 10-Aug-2011 85HGC 3002834291 Mian Shahid Corporation Pakistan
 
W69-3193764-4/9/1 26-Aug-2011 85HGX 3008455432 Tung Ling Industrial Co Ltd Taiwan
 
MR5-2020209-1/5/1 18-Aug-2011 85HHL 3008032516 Atomy Co., Ltd. Korea, Republic Of (South)
 
MR5-2020209-1/5/2 18-Aug-2011 85HHL 3008032516 Atomy Co., Ltd. Korea, Republic Of (South)
 
BJV-0241386-3/14/1 10-Aug-2011 85HHM 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
112-2035072-7/1/1 05-Aug-2011 85HIS 3002807528 Artsana S.p.A. Italy
 
AEK-8462995-1/1/1 15-Aug-2011 85HIS 3003904726 Shanghai Dahu Fashion & Adornment Co., China
 
XXX-0175547-0/1/1 23-Aug-2011 85HIS 3000537299 Unknown Thailand
 
XXX-0175547-0/1/2 23-Aug-2011 85HIS 3000537299 Unknown Thailand
 
XXX-0175547-0/1/3 23-Aug-2011 85HIS 3000537299 Unknown Thailand
 
XXX-0175547-0/1/4 23-Aug-2011 85HIS 3000537299 Unknown Thailand
 
AEG-0011292-1/46/1 26-Aug-2011 85HIS 3008984859 Pleasure Chest Group Company Ltd China
 
AEG-0011292-1/42/1 19-Aug-2011 85KXQ 3008984859 Pleasure Chest Group Company Ltd China
 
112-0209827-8/1/1 24-Aug-2011 85LHD 3008687430 Ms Kirat Plastics Pvt India
 
BJY-0709124-0/3/12 18-Aug-2011 85LKF 3005657189 Purple Surgical International United Kingdom
 
BJY-0709124-0/3/13 18-Aug-2011 85LKF 3005657189 Purple Surgical International United Kingdom
 
531-0269467-5/1/1 02-Aug-2011 85MGK 3008976962 Kim Sung Rak Medex Korea, Republic Of (South)
 
112-0507544-8/1/1 23-Aug-2011 85MHK 3008456389 Kitazato Medical Co Ltd Japan
 
853-0525573-0/28/1 01-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527235-4/10/1 05-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525474-1/2/1 09-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525540-9/2/1 09-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525557-3/22/1 09-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527247-9/9/1 22-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0527247-9/22/1 22-Aug-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
112-0507544-8/2/1 23-Aug-2011 85MQF 3008456389 Kitazato Medical Co Ltd Japan
 
112-1608094-0/1/1 23-Aug-2011 85MQK 3007530035 Kitazato Biopharma Co., Ltd. Japan
 
112-7306095-8/1/1 05-Aug-2011 85MQL 3007530035 Kitazato Biopharma Co., Ltd. Japan
 
112-1454294-1/1/1 23-Aug-2011 85MQL 3007530035 Kitazato Biopharma Co., Ltd. Japan
 
BJY-0709124-0/3/9 18-Aug-2011 85NKC 3005657189 Purple Surgical International United Kingdom
 
112-2752734-3/1/1 31-Aug-2011 85OHH 3007349355 Providence Enterprise China
 
BJV-0243916-5/53/3 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/42/3 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/10 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/81/4 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/71/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/8 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/56/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/11 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/8 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/66/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/79/1 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/7 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/12 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/12 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/93/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/75/1 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/66/3 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/11 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/7 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/13 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/9 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/13 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/90/10 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/68/3 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/12 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/9 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/8 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/10 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/43/6 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/12 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/84/4 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/90/9 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/84/3 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/8 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/6 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/42/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/11 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/13 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/6/2 31-Aug-2011 85OHM 3004710519 Convertors De Mexico Mexico
 
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