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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
799-0727677-2/1/1 07-Nov-2013 80FLE 3008290541 Kavo Do Brasil Ind. E Com. Ltda. Brazil
 
799-0851758-8/1/1 08-Nov-2013 80FLE 3010378225 Kavo Do Brasil Industria Brazil
 
767-0037851-6/1/1 27-Nov-2013 80FLE 3005343391 Tuttnauer Co., Ltd Israel
 
799-1000686-9/1/1 13-Nov-2013 80FLL 3010228378 Flender Graffenstaden France
 
231-6865124-2/1/1 22-Nov-2013 80FLL 3010028075 Cotronic Technology Ltd China
 
MH9-2020316-2/1/1 29-Nov-2013 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
799-1533215-3/1/1 04-Nov-2013 80FPA 3000254235 Insung Medical Co Ltd Korea, Republic Of (South)
 
BAH-0002043-6/5/1 08-Nov-2013 80FRJ 3010407973 Suncare Medical Products Co Ltd China
 
FR1-0015308-4/3/1 13-Nov-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
T94-0060609-9/3/1 07-Nov-2013 80GCX 3010436667 Shanghai Keling International Trading Co Ltd China
 
T94-0060609-9/4/1 07-Nov-2013 80GCX 3010436667 Shanghai Keling International Trading Co Ltd China
 
799-1062422-4/1/3 29-Nov-2013 80KDP 3004966675 Amvex Corporation Canada
 
799-1062422-4/2/1 29-Nov-2013 80KDP 3004966675 Amvex Corporation Canada
 
799-1062422-4/1/2 29-Nov-2013 80KDQ 3004966675 Amvex Corporation Canada
 
799-1062422-4/1/5 29-Nov-2013 80KDQ 3004966675 Amvex Corporation Canada
 
AEK-1140231-6/5/1 29-Nov-2013 80KGX 3010443163 Agrncia Maritima Nabsa Sa Argentina
 
UPS-2746044-5/1/1 04-Nov-2013 80KMJ 3005529175 California Exotica United States
 
UPS-2746044-5/2/1 04-Nov-2013 80KMJ 1000255046 Doc Johnson Enterprises United States
 
UPS-2746044-5/3/1 04-Nov-2013 80KMJ 1000255046 Doc Johnson Enterprises United States
 
UPS-2746044-5/4/1 04-Nov-2013 80KMJ 1000255046 Doc Johnson Enterprises United States
 
BQB-0012075-7/2/1 27-Nov-2013 80KMJ 1000611011 Limbs & Things Ltd United Kingdom
 
UPS-2785263-3/1/1 08-Nov-2013 80LDQ 3010209329 Hightech Development S.R.O. Czech Republic
 
EQ6-0017344-5/1/1 14-Nov-2013 80LDQ 5833 EPPENDORF AG Germany
 
UPS-2867842-5/1/1/B 21-Nov-2013 80LDQ 3010448325 Ism Clinic & Lab Canada
 
799-1110804-5/1/1 25-Nov-2013 80LLI 3010411520 Camex Wellness Ltd India
 
UPS-2945581-5/1/1 07-Nov-2013 80LLK 3005818738 Moore Spa Incorporated Canada
 
UPS-2945581-5/2/1/B 07-Nov-2013 80LLK 3005818738 Moore Spa Incorporated Canada
 
MC2-6405442-0/1/1 01-Nov-2013 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
MC2-6403337-4/1/1 07-Nov-2013 80LYZ 3008388240 Hebei Handform Plastic Products Co., Ltd. China
 
MC2-6403337-4/2/1 07-Nov-2013 80LYZ 3008388240 Hebei Handform Plastic Products Co., Ltd. China
 
MC2-6403159-2/1/1 18-Nov-2013 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
609-0328916-7/1/1 05-Nov-2013 80LZA 3003346215 Formosa Glove Industrial Co Taiwan
 
799-0815688-2/1/1 01-Nov-2013 80LZG 3004173703 Flextronics Industrial (Shenzhen) Co. China
 
E84-0077588-6/3/1 04-Nov-2013 80MEG 3010407173 Sphynx Medical Canada
 
175-3117219-9/15/1 15-Nov-2013 80OPD 3006433175 JIANGSU SAINTY GLORIOUS TRADE CO., LTD China
 
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