12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DropSafe Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 8, 2023
BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 4, 2023
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
FDA 510(k)
FDA Class 2
·General Hospital
HUMAPEN LUXURA HD
FDA 510(k)
FDA Class 2
·General Hospital
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·June 14, 2013
STRYKEFLOW II
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code GCX·July 15, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014
HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·August 24, 2018
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 20, 2023
PERFORMER MULLINS GUIDING SHEATH
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·January 24, 2024
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022