• 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 87-Orthopedic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
D40-0355518-0/1/1 21-Aug-2013 87HRS 3003414678 Syntec Scientific Corporation Taiwan
 
112-3342209-2/1/1 01-Aug-2013 87HRX 3008664544 Shenyang Shenda Endoscope Co., Ltd. China
 
406-0493285-1/12/10 15-Aug-2013 87HRY 3010307616 Fenin Spain
 
BJY-0711497-6/1/2 15-Aug-2013 87HRZ 3003501639 Beijing Jinghua Corp. Of Foreing Trade & Economic Co-Op China
 
112-3734591-9/1/1 26-Aug-2013 87HSD 3006487372 Gsell Medical Plastics Ag Switzerland
 
406-0493285-1/13/2 15-Aug-2013 87HSP 3003999451 Fresco Podologia S.L. Spain
 
799-0302649-4/12/1 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
799-0302649-4/12/2 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
799-0354744-0/13/1 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
799-0354744-0/14/1 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
799-0252918-3/6/1 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
799-0252918-3/6/2 09-Aug-2013 87HST 3006528349 Intop Tech Co Ltd 2005 Dragon Bearl China
 
112-3445757-6/1/1 19-Aug-2013 87HTO 3006356426 Fh Orthopedics France
 
112-3445757-6/1/2 19-Aug-2013 87HTO 3006356426 Fh Orthopedics France
 
406-0493285-1/12/15 15-Aug-2013 87HWC 3010307616 Fenin Spain
 
E4K-0046014-2/2/8 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/5 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/6 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/4 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/4 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/3 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/9 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/3 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/6 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/7 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/7 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/2 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/2/1 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/2 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/5 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/3/1 26-Aug-2013 87HWC 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
406-0493285-1/12/8 15-Aug-2013 87JDI 3010307616 Fenin Spain
 
406-0493285-1/12/11 15-Aug-2013 87KTT 3010307616 Fenin Spain
 
406-0493285-1/13/1 15-Aug-2013 87KWH 3003999451 Fresco Podologia S.L. Spain
 
406-0493285-1/12/1 15-Aug-2013 87KWL 3010307616 Fenin Spain
 
E4K-0046014-2/1/1 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/2 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/7 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/3 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/4 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/5 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/6 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
E4K-0046014-2/1/8 26-Aug-2013 87KWL 3010256582 CRITICARE SURGICALS & LABORATORY SUPPLIES India
 
406-0493285-1/12/12 15-Aug-2013 87KWQ 3010307616 Fenin Spain
 
406-0493285-1/12/2 15-Aug-2013 87KWY 3010307616 Fenin Spain
 
406-0493285-1/12/5 15-Aug-2013 87KWY 3010307616 Fenin Spain
 
BJY-0711497-6/1/3 15-Aug-2013 87KXD 3003501639 Beijing Jinghua Corp. Of Foreing Trade & Economic Co-Op China
 
406-0493285-1/12/6 15-Aug-2013 87LWJ 3010307616 Fenin Spain
 
112-3595904-2/1/1 09-Aug-2013 87LXH 3000326506 Falcon Surgical Co. (Pvt.) Ltd. Pakistan
 
112-3595904-2/1/2 09-Aug-2013 87LXH 3000326506 Falcon Surgical Co. (Pvt.) Ltd. Pakistan
 
112-3725671-0/1/1 23-Aug-2013 87LXH 3003294587 Cases By Source United States
 
406-0493285-1/12/3 15-Aug-2013 87LZN 3010307616 Fenin Spain
 
406-0493285-1/12/7 15-Aug-2013 87LZO 3010307616 Fenin Spain
 
406-0493285-1/12/4 15-Aug-2013 87LZY 3010307616 Fenin Spain
 
406-0493285-1/12/9 15-Aug-2013 87MBH 3010307616 Fenin Spain
 
406-0493285-1/12/13 15-Aug-2013 87MCV 3010307616 Fenin Spain
 
406-0493285-1/12/16 15-Aug-2013 87MOO 3010307616 Fenin Spain
 
406-0493285-1/12/14 15-Aug-2013 87NDH 3010307616 Fenin Spain
 
BJY-0711497-6/1/1 15-Aug-2013 87NTG 3003501639 Beijing Jinghua Corp. Of Foreing Trade & Economic Co-Op China
 
-
-