• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

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
T94-0058231-6/1/1 16-Oct-2012 80FLK 3006716626 NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. China
 
231-3237135-6/1/1 30-Oct-2012 80FLL 3008279548 Kaz Europe Sa Switzerland
 
561-0090723-9/2/1 10-Oct-2012 80FMC 1000153304 Brightway Holdings SDN BHD Malaysia
 
FR1-0014360-6/1/1 17-Oct-2012 80FMF 3005405146 Shanghai Kindly Enterprise Development Group Co., Ltd. China
 
853-7460430-5/240/1 05-Oct-2012 80FMG 3005519694 Icu Medical De Mexico S.A. De C.V. Mexico
 
336-7340636-3/2/1 15-Oct-2012 80FMI 3004023840 Arriol International Corp. Dominican Republic
 
MH9-2003873-3/2/2 02-Oct-2012 80FMT 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-2003873-3/2/1 02-Oct-2012 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-2005507-5/1/1 24-Oct-2012 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
BYV-0025222-7/1/1 01-Oct-2012 80FNL 3009707351 Foshan Shunde Goodluck Tent Products Co Ltd China
 
FR1-0014622-9/3/1 01-Oct-2012 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014427-3/3/1 17-Oct-2012 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014465-3/2/1 17-Oct-2012 80FOZ 3004070915 Hanako Medical Japan
 
FR1-0014631-0/1/1 01-Oct-2012 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
BYV-0025222-7/3/1 01-Oct-2012 80FPP 3009707351 Foshan Shunde Goodluck Tent Products Co Ltd China
 
UPS-7778472-2/1/1 04-Oct-2012 80FQM 3007701889 Reliance Medical L United Kingdom
 
112-9242715-5/1/1 12-Oct-2012 80FQM 3009725579 Yangzhou Qionghua Sports China
 
112-9242715-5/1/2 12-Oct-2012 80FQM 3009725579 Yangzhou Qionghua Sports China
 
M76-1890074-2/14/1 19-Oct-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
M76-1890074-2/16/1 19-Oct-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
M76-1890074-2/25/1 19-Oct-2012 80FQM 3005052406 Chain Medical Products Co., Ltd. China
 
FR1-0014586-6/3/1 03-Oct-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014463-8/2/1 17-Oct-2012 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
UPS-7967758-5/2/1 19-Oct-2012 80KGX 3002966884 Natural Products United Kingdom
 
UPS-4490051-6/16/1 24-Oct-2012 80KGX 3005052406 Chain Medical Products Co., Ltd. China
 
772-0252920-0/34/1 09-Oct-2012 80KMH 3009700166 Shantou Xinghe Electrical Apparatuses Co Ltd China
 
AEK-0411788-9/1/1 16-Oct-2012 80KZH 3009639877 Beauty Equipment Co Ltd Hong Kong SAR
 
EQ6-0015632-5/1/1 25-Oct-2012 80LDQ 5833 EPPENDORF AG Germany
 
196-2504402-9/4/1 09-Oct-2012 80LJL 3003301354 International Custom Pak Inc. Canada
 
WC1-8539158-6/275/1 05-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
561-0090723-9/1/1 10-Oct-2012 80LYY 1000153304 Brightway Holdings SDN BHD Malaysia
 
WC1-8540124-5/386/1 11-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8540141-9/276/1 11-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8537856-7/314/1 15-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541679-7/178/1 15-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541800-9/40/1 15-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538493-8/265/1 17-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8547202-2/365/1 18-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546321-1/222/1 18-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8546804-6/390/1 19-Oct-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
MC2-6341567-1/1/1 19-Oct-2012 80LYZ 3009137438 SHIJIAZHUANG GLORY PLASTIC CO LTD China
 
224-2080507-3/1/1 01-Oct-2012 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
224-2080507-3/1/2 01-Oct-2012 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
224-2080507-3/1/3 01-Oct-2012 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
224-2080507-3/1/4 01-Oct-2012 80LZA 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
WC1-8539638-7/153/1 04-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539638-7/152/1 04-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8539101-6/37/1 05-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538413-6/65/1 05-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8537833-6/98/1 05-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538832-7/118/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538832-7/156/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541151-7/143/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541268-9/23/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541268-9/43/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541268-9/79/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541268-9/80/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541612-8/4/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541612-8/85/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541612-8/86/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8541616-9/259/1 15-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
GL5-0281391-5/1/1 15-Oct-2012 80LZA 3009496546 Shandong Yinghong Medical Products Co Ltd China
 
WC1-8539082-8/326/1 19-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538811-1/150/1 22-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538821-0/341/1 22-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
231-1257947-3/1/1/A 23-Oct-2012 80LZA 3006993432 HL Rubber Industries SDN BHD Malaysia
 
231-1257947-3/1/1/B 23-Oct-2012 80LZA 3006993432 HL Rubber Industries SDN BHD Malaysia
 
231-1257591-9/1/1 23-Oct-2012 80LZA 3006993432 HL Rubber Industries SDN BHD Malaysia
 
WC1-8542231-6/25/1 26-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8542266-2/199/1 29-Oct-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
112-9717801-9/1/1 18-Oct-2012 80MQX 3009774784 Suzhou Huading Body-Building Equipment Co., China
 
112-9717801-9/1/2 18-Oct-2012 80MQX 3009774784 Suzhou Huading Body-Building Equipment Co., China
 
ACN-5025904-1/4/1 31-Oct-2012 80NPC 3009778285 Yangzhou Dainty Import And Export Co Ltd China
 
-
-