15 results · 22ms · Sources: EU EUDAMED, 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