• 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
112-0472211-5/1/1 23-Aug-2011 87HRS 3008357516 Ananta Ortho Systems India
 
112-2194798-4/2/1 23-Aug-2011 87HSZ 1000478621 Sodem Diffusion Sa Switzerland
 
112-0472211-5/5/1 23-Aug-2011 87HTW 3008357516 Ananta Ortho Systems India
 
523-0941819-3/5/1 30-Aug-2011 87HTX 3009058024 Rebstock Instruments Germany
 
112-2360567-1/1/4 23-Aug-2011 87HTY 3006765916 Fournitures Hospitalieres France
 
112-2360567-1/2/1 23-Aug-2011 87HWC 3006356426 Fh Orthopedics France
 
112-2360567-1/1/3 23-Aug-2011 87HWC 3006765916 Fournitures Hospitalieres France
 
112-0472211-5/2/1 23-Aug-2011 87HWC 3008357516 Ananta Ortho Systems India
 
112-2864563-1/1/3 29-Aug-2011 87HXB 3008684204 Faizan Surgical Pakistan
 
BJV-0240971-3/73/10 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0240975-4/78/9 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0240975-4/78/5 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241005-9/84/9 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241005-9/84/5 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241231-1/40/2 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0241243-6/79/6 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241243-6/79/9 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241243-6/79/10 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241342-6/49/1 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241346-7/78/4 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241346-7/78/7 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241363-2/83/4 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241366-5/79/4 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241391-3/91/5 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241757-5/80/11 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241774-0/85/6 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241774-0/85/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241774-0/85/4 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241827-6/83/9 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241827-6/83/13 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241827-6/83/5 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241859-9/72/6 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241859-9/72/10 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0241859-9/72/9 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241875-5/85/6 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0241875-5/85/9 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0241875-5/85/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242016-5/105/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242199-9/83/10 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242199-9/83/4 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242252-6/62/3 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242389-6/48/4 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242643-6/74/5 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242665-9/79/13 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242665-9/79/7 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242665-9/79/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242665-9/79/10 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242716-0/73/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242734-3/85/14 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242734-3/85/8 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242763-2/29/7 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242763-2/29/1 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242763-2/29/12 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242765-7/85/3 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242779-8/58/1 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242867-1/79/13 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242867-1/79/14 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242867-1/79/8 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242867-1/79/4 10-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242867-1/79/10 10-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242970-3/64/1 11-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0242972-9/75/7 11-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242996-8/60/7 11-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0242996-8/60/1 11-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
BJV-0243088-3/88/4 11-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0243175-8/81/5 11-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0243175-8/81/4 11-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0243441-4/80/3 17-Aug-2011 87HXK 3002808350 Tinopal Surgical Corp. (Pvt) Ltd. Pakistan
 
BJV-0243444-8/83/1 17-Aug-2011 87HXK 3002834291 Mian Shahid Corporation Pakistan
 
112-1651121-7/1/2 23-Aug-2011 87KWQ 3008844415 Eden Spine Europe SA Switzerland
 
112-3463812-5/60/1 24-Aug-2011 87KXE 3002494911 Dismed Inc Canada
 
BJV-0242389-6/15/3 10-Aug-2011 87LGF 3004710519 Convertors De Mexico Mexico
 
BJV-0242389-6/7/2 10-Aug-2011 87LGF 3004710519 Convertors De Mexico Mexico
 
112-2194365-2/1/1 23-Aug-2011 87LXI 3008732302 Soplus Switzerland
 
112-1651121-7/1/1 23-Aug-2011 87MAX 3008844415 Eden Spine Europe SA Switzerland
 
112-2360567-1/2/2 23-Aug-2011 87MEH 3006356426 Fh Orthopedics France
 
112-2360567-1/2/3 23-Aug-2011 87MEH 3006356426 Fh Orthopedics France
 
BJV-0243916-5/22/4 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/10 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/13 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/19 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/18 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/11/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/9/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/84/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/13 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/61/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/11 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/66/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/70/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/11 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/15 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/25 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/16 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/87/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/53/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/18 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/15 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/22/3 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/19 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/47/15 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/10 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/8 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/77/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/11 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/20/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/81/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/46/4 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/45/8 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/42/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/46/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/12/8 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/90/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/9/8 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/22/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/29/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/15 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/16 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/46/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/8/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/18 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/18 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/81/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/20 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/57/3 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/15/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/63/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/11 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/70/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/27/3 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/21/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/26/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/27/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/43/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/45/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/16 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/46/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/53/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/9/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/90/11 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/71/4 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/20 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/10 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/79/2 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/73/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/45/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/44/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/7/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/17 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/2/20 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/91/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/90/13 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/9/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/71/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/58/7 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/74/13 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/79/3 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/43/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/25/12 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/30/18 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/43/10 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/83/14 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/53/4 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/84/5 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/88/1 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/92/19 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/65/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/58/6 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/72/13 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
BJV-0243916-5/80/9 31-Aug-2011 87OJH 3004710519 Convertors De Mexico Mexico
 
-
-