3,608 results
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39ms
·
Sources: EU EUDAMED, US FDA
THEIA MEDICAL
FDA registration
THEIA MEDICAL·1 product·🇺🇸 United States
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·December 15, 2020
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 2, 2016
WATCHMAN FXD CURVE ACCESS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·June 18, 2024
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 17, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·December 4, 2019
O-ARM 1000 IMAGING SYSTEM 3RD EDITION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·September 9, 2020
ALTO
FDA Adverse Event
Injury
·ENDOLOGIX SANTA ROSA·Product code MIH·February 21, 2024
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·June 7, 2021
SOLO IA TIP, 45 DEG, .3MM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·May 10, 2016
EMBLEM MRI S-ICD
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 13, 2021
SOLO IA TIP, 45 DEG, .3MM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·May 10, 2016
CLAREON IOL
FDA Adverse Event
Injury
·ALCON LABORATORIES IRELAND LTD.·Product code HQL·September 13, 2024
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 21, 2016
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 4, 2016
O-ARM 1000 IMAGING SYSTEM 3RD EDITION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 4, 2016
SOLO IA TIP, 45 DEG, .3MM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·May 10, 2016
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·August 21, 2019
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·September 10, 2020