15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Philips Ingenuity CT
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
FDA 510(k)
FDA Class 2
·General Hospital
ATLAS SPINE PIVOTING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·July 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 26, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 21, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·April 24, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·October 3, 2019
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 10, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011
SUNBEAM
FDA Adverse Event
Malfunction
·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·September 8, 2008
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·August 23, 2019
ULTRASAFE X100L PR PLUM SSL NVS STEIN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·March 28, 2019
ULTRASAFE X100L PR GREY SSL SDZ
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code MEG·September 11, 2019
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026