11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CNS Envision
FDA 510(k)
FDA Class 2
·Neurology
BD PHOENIX¿ PMIC/ID-106
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 18, 2024
CORE*IT DUAL
FDA 510(k)
FDA Class 2
·Dental
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·September 30, 2019
ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·September 30, 2019
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 8, 2008
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 19, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FPO·June 30, 2011
BD PHOENIX¿ PMIC/ID-106
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 13, 2024
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020