28 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITALAB MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
THERMOFLEX SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 28, 2024
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·February 13, 2024
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 3, 2013
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL LTD.·Product code KYF·March 18, 2011
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·July 7, 2014
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 18, 2024
ULTRAFLEX ESOPHAGEAL NG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·April 10, 2023
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·December 5, 2023
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·January 13, 2021
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·July 3, 2017
ULTRAFLEX TRACHEOBRONCHIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·February 23, 2026
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 4, 2018
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 1, 2018
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 23, 2018
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 12, 2017
ZILVER 635 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·May 30, 2014