• 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 74-Cardiovascular


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7825578-6/1/1 28-Jun-2012 74DQA 3009566572 Beijing Safe Heart Technology China
 
322-0685367-7/4/1 08-Jun-2012 74DQR 3007165178 WEBER MEDICAL GMBH Germany
 
112-5582499-1/1/1 19-Jun-2012 74DQY 3006385193 Shincotec Japan
 
101-9822240-7/4/1 06-Jun-2012 74DRS 3009471097 Edwards Lifesciences Ag Dominican Republic
 
112-7185615-0/1/1 11-Jun-2012 74DRT 3003983663 Burdick Inc United States
 
112-9984169-6/1/1 01-Jun-2012 74DTD 3005867894 Accellent Ireland
 
112-5557293-9/1/1 20-Jun-2012 74DTD 3002618605 Boston Scientific Clonmel, Ltd. Ireland
 
112-5557279-8/1/1 20-Jun-2012 74DTD 3002618605 Boston Scientific Clonmel, Ltd. Ireland
 
112-6316404-2/1/1 18-Jun-2012 74DTL 1033554 DeRoyal Industries, Inc. United States
 
101-9823774-4/1/1 04-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9823766-0/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9823770-2/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9822240-7/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9822294-4/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9818369-0/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816137-3/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816212-4/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816250-4/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816346-0/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9813219-2/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9813116-0/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9813166-5/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9812987-5/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9809495-4/4/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9809166-1/2/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9809466-5/2/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9849199-4/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9822592-1/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816429-4/2/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816429-4/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9805470-1/4/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9805303-4/3/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9801470-5/2/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9801623-9/4/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9792548-9/3/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9792339-3/4/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9865185-2/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9792592-7/4/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9863051-8/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9863054-2/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9863058-3/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9865181-1/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9865184-5/1/1 06-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9871975-8/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9871765-3/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9873000-3/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9873018-5/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9873035-9/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9873056-5/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877389-6/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9873091-2/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9875007-6/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9875022-5/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9875078-7/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9877339-1/1/1 21-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9888446-1/1/1 27-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9830045-0/1/1 27-Jun-2012 74DXO 3009471097 Edwards Lifesciences Ag Dominican Republic
 
112-7469232-0/3/1 19-Jun-2012 74DYE 3003956144 Admedes Schuessler GmbH Germany
 
112-7469232-0/1/1 19-Jun-2012 74DYE 3003956144 Admedes Schuessler GmbH Germany
 
112-7469232-0/4/1 19-Jun-2012 74DYE 3003956144 Admedes Schuessler GmbH Germany
 
112-7469232-0/2/1 19-Jun-2012 74DYE 3003956144 Admedes Schuessler GmbH Germany
 
112-2400520-2/1/1 04-Jun-2012 74JOP 3002936985 Aga Khan Hre Ismaelee Federal Councial For Community & Socia Pakistan
 
112-6823771-1/1/1 01-Jun-2012 74JOW 3009459598 Debby Knit Ltd Israel
 
101-9822240-7/2/1 06-Jun-2012 74KRA 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9823770-2/3/1 06-Jun-2012 74KRB 3009471097 Edwards Lifesciences Ag Dominican Republic
 
101-9816429-4/3/1 06-Jun-2012 74KRB 3009471097 Edwards Lifesciences Ag Dominican Republic
 
112-7707157-2/1/1 13-Jun-2012 74KRG 3001504994 Medtronic Inc United States
 
112-6834933-3/1/1 20-Jun-2012 74KRI 3006452343 Nellcor Puritan Bennett Inc United States
 
MH9-2001329-8/1/1 29-Jun-2012 74MKJ 3009578283 Le-Cor Co Ltd China
 
112-7548806-6/1/1 11-Jun-2012 74NIP 3009937642 Meko Germany
 
BJV-0244691-3/38/3 21-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245152-5/23/3 25-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245160-8/2/2 25-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245179-8/39/1 25-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245182-2/29/1 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245204-4/11/2 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245205-1/22/1 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245224-2/52/2 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245230-9/2/2 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245230-9/41/11 27-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245243-2/23/2 28-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0245244-0/45/1 28-Jun-2012 74OEQ 3004710519 Convertors De Mexico Mexico
 
BJV-0244381-1/19/14 12-Jun-2012 74OEZ 3004710519 Convertors De Mexico Mexico
 
BJV-0244107-0/2/5 18-Jun-2012 74OEZ 3004710519 Convertors De Mexico Mexico
 
BJV-0244763-0/2/10 21-Jun-2012 74OEZ 3004710519 Convertors De Mexico Mexico
 
BJV-0244777-0/55/9 21-Jun-2012 74OEZ 3004710519 Convertors De Mexico Mexico
 
BJV-0245201-0/90/1 27-Jun-2012 74OEZ 3004710519 Convertors De Mexico Mexico
 
-
-