4,951 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Syrebo
FDA UDI
Shanghai SiYi Intelligent Technology Co., Ltd.·06973408900019·The product is suitable for patients with certa...
AeroDVx ™
FDA UDI
SUN SCIENTIFIC, INC.·00856525007723·The AeroDVx ™ System is comprised of a gradient...
4X4,ISLAND DRESSING,STERILE 50/BX
FDA Adverse Event
Injury
·RITMED·Product code KGX·September 3, 2025
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
FDA Recall
Terminated
·Product code FGE·August 1, 2005
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
3009495988-2015-00007
FDA Adverse Event
Malfunction
·November 16, 2015
BD INSYTE AUTOG BC YEL 24GA X 0.75IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 1, 2025
3009495988-2015-00001
FDA Adverse Event
Malfunction
·August 6, 2015
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 16, 2024
CYPHER BX JAPAN 3.50 X 18 MM
FDA Adverse Event
Death
·CORDIS CASHEL·Product code NIQ·December 11, 2017
3009495988-2015-00005
FDA Adverse Event
Malfunction
·October 7, 2015
3009495988-2015-00006
FDA Adverse Event
Malfunction
·October 20, 2015
3009495988-2015-00004
FDA Adverse Event
Malfunction
·September 2, 2015
3009495988-2015-00003
FDA Adverse Event
Malfunction
·September 2, 2015
GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code PRL·September 25, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 5, 2010
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·March 30, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·January 17, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·July 14, 2011
3009495988-2015-00002
FDA Adverse Event
Malfunction
·August 12, 2015