• 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
FR1-0015462-9/1/1 19-Feb-2014 80FLK 3008303451 SHANGHAIHUACHEN MEDICAL INSTRUMENTS CO., LTD China
 
799-2633252-3/2/1 05-Feb-2014 80FLL 3010570835 Radiant Innovations China
 
799-2633252-3/2/2 05-Feb-2014 80FLL 3010570835 Radiant Innovations China
 
799-2303742-2/1/1 06-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2745762-6/1/1 21-Feb-2014 80FLL 3003208309 Actherm Inc. Taiwan
 
799-2295349-6/1/1 27-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2287372-8/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2287404-9/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2292952-0/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2287390-0/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2288308-1/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2292711-0/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2288493-1/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2303390-0/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2292819-1/1/1 28-Feb-2014 80FLL 3004215929 COTRONIC TECHNOLOGY LIMITED China
 
799-2807636-7/1/1 28-Feb-2014 80FLL 3006537699 THERMOR LTD. Canada
 
XXX-0220752-1/1/5 28-Feb-2014 80FMI 3004324407 Rymco (Pty) Ltd South Africa
 
EDX-0010900-9/1/2 11-Feb-2014 80FOZ 3009655546 Redax S.R.L. Italy
 
FR1-0015412-4/1/1 11-Feb-2014 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
FR1-0015444-7/1/1 14-Feb-2014 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
FR1-0015409-0/1/1 14-Feb-2014 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
FR1-0015436-3/3/1 14-Feb-2014 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
EDX-0010920-7/2/1 13-Feb-2014 80FRW 3010583121 Machan International Co.,Ltd Taiwan
 
277-0142856-0/1/1 03-Feb-2014 80KGX 3003514271 Jiangsu Nanfang Medical Co. China
 
UPS-4028952-4/1/1 26-Feb-2014 80KZE 3006733982 Interquest Ltd United Kingdom
 
UPS-4171474-4/2/1 27-Feb-2014 80KZE 3003200511 Biotekne Srl Italy
 
UPS-4171474-4/1/1 27-Feb-2014 80KZH 3003200511 Biotekne Srl Italy
 
EDX-0010920-7/1/1 13-Feb-2014 80LGX 3010583121 Machan International Co.,Ltd Taiwan
 
NE9-0122863-9/1/1 25-Feb-2014 80LGZ 3005982366 Bao Hui China
 
791-0102602-4/8/1 10-Feb-2014 80LYY 3003994600 Top Glove (Zhangjigang) Co., Ltd. China
 
349-0954131-9/1/1 20-Feb-2014 80LYY 3000239897 Pt. Maja Agung Latexindo Indonesia
 
349-0954131-9/1/2 20-Feb-2014 80LYY 3000239897 Pt. Maja Agung Latexindo Indonesia
 
349-0954320-8/3/1 20-Feb-2014 80LYY 3000239897 Pt. Maja Agung Latexindo Indonesia
 
F23-9095126-7/1/1 11-Feb-2014 80LYZ 3004167063 Zibo Borui Plastic & Rubber Products Co., Ltd. China
 
MC2-6422591-3/1/1 21-Feb-2014 80LYZ 3008388240 Hebei Handform Plastic Products Co., Ltd. China
 
AEK-1684511-3/1/1 06-Feb-2014 80MQX 3010505061 Guangzhou Wdm Electronic Co Ltd China
 
N16-1055349-0/1/1 04-Feb-2014 80NPC 3009130943 WEIFANG BEIHAI COLOR PRINTING PACKAGING CO., LTD China
 
N16-1055349-0/1/2 04-Feb-2014 80NPC 3009130943 WEIFANG BEIHAI COLOR PRINTING PACKAGING CO., LTD China
 
N16-1055349-0/1/3 04-Feb-2014 80NPC 3009130943 WEIFANG BEIHAI COLOR PRINTING PACKAGING CO., LTD China
 
N16-1055349-0/1/4 04-Feb-2014 80NPC 3009130943 WEIFANG BEIHAI COLOR PRINTING PACKAGING CO., LTD China
 
390-4339911-0/5/1/A 20-Feb-2014 80NPC 3009130943 WEIFANG BEIHAI COLOR PRINTING PACKAGING CO., LTD China
 
EDX-0010900-9/1/1 11-Feb-2014 80PAD 3009655546 Redax S.R.L. Italy
 
-
-