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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 79-General & Plastic Surgery


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
799-2009730-4/2/1 16-Jan-2014 79DZG 3003862567 American Dental Systems Germany
 
799-1624731-9/1/1 22-Jan-2014 79DZG 3003607686 Serag-Wiessner Kg Germany
 
799-2341594-1/1/1 10-Jan-2014 79FRO 3009131405 Detectamet Ltd United Kingdom
 
799-2341594-1/1/2 10-Jan-2014 79FRO 3009131405 Detectamet Ltd United Kingdom
 
UPS-3645450-4/1/1 15-Jan-2014 79FTN 3009271861 4dimens Aps Denmark
 
799-2513075-3/1/1 23-Jan-2014 79GAP 3010054282 Shaanxi Lsnm Tech Co., Ltd China
 
799-1993288-3/1/1 16-Jan-2014 79GDI 3010513330 Traumec Tecnologia Brazil
 
799-1825809-0/1/1 16-Jan-2014 79GDW 3008395038 Changzhou Kangdi Medical Stapler Co., Ltd China
 
AV3-0040930-5/7/1 15-Jan-2014 79GEI 3001451571 ConMed Corporation United States
 
AV3-0040930-5/8/1 15-Jan-2014 79GEI 3007960282 Olympus Medical Products Czech Czech Republic
 
799-1993288-3/2/1 16-Jan-2014 79GES 3010513330 Traumec Tecnologia Brazil
 
551-0944899-9/1/8 10-Jan-2014 79GFD 3009112562 Depot Cosmotec Sa Switzerland
 
551-0944899-9/18/2 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/18/3 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/23/17 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/23/29 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/25/2 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/27/1 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
551-0944899-9/27/2 10-Jan-2014 79GFD 3005545844 Silhouet-Tone, Ltd. Canada
 
799-1721715-4/1/1 13-Jan-2014 79HTD 3010479653 Pak Rehman Industries Pakistan
 
UPS-3821355-1/1/1 21-Jan-2014 79HXD 3009271861 4dimens Aps Denmark
 
UPS-3703414-9/1/1 23-Jan-2014 79HXD 3009271861 4dimens Aps Denmark
 
UPS-3755075-5/1/1 23-Jan-2014 79HXD 3009271861 4dimens Aps Denmark
 
UPS-3821067-2/1/1 29-Jan-2014 79HXD 3010440271 4dimens Denmark
 
799-1994229-6/1/1 16-Jan-2014 79KDD 3009220482 Farla Medical Ltd United Kingdom
 
FR1-0015398-5/1/1 28-Jan-2014 79KGX 3001104810 Toyo Kagaku Co Japan
 
799-2541429-8/1/1 24-Jan-2014 79KQM 3004631559 National Dental Inc Canada
 
799-2408741-8/1/1 16-Jan-2014 79LRO 3003965684 Sarl Mdj France
 
9FE-1311020-3/6/2 06-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
9FE-1311020-3/6/6 06-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
9FE-1311020-3/6/5 06-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
9FE-1311020-3/6/4 06-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
9FE-1311020-3/6/3 06-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
9FE-1311020-3/6/1 07-Jan-2014 79LRR 3010279364 Hd Package Korea, Republic Of (South)
 
799-1640359-9/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-1640359-9/2/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2164200-9/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2164277-7/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2189484-0/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2189535-9/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2189597-9/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2189648-0/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-2298478-0/1/1 09-Jan-2014 79LRR 1619634 Banyan International Corp United States
 
799-1882718-3/1/1 09-Jan-2014 79MDM 3007361698 DERMAROLLER GMBH Germany
 
799-2230125-8/1/1 10-Jan-2014 79MDM 3010553348 Firstlub Outdoor & Sports Co., Ltd China
 
799-2166970-5/1/1 16-Jan-2014 79MGQ 3008197143 Erfa Sa Belgium
 
231-7342914-7/1/1 07-Jan-2014 79OHS 3010482432 Shantou City Kin Seng Plastic Co Lt China
 
AEK-1689934-2/1/1 23-Jan-2014 79OHV 3010534182 Vmed Group Co Ltd China
 
799-1746261-0/1/1 13-Jan-2014 79OUH 3009852131 Nearbyexpress.Com Ltd China
 
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