21 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ManaFlexx 2 (model: MF002-RX, MF002-OTC)
FDA 510(k)
FDA Class 2
·Neurology
BD BBL™ Sensi-Disc™ Tobramycin 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902315699·BD BBL™ Sensi-Disc™ Tobramycin 10 µg
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
FDA 510(k)
FDA Class 2
·Cardiovascular
PG-800A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025
LYNX ULTRA SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025
SYNCHRO 2 GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIVISION·Product code DQX·November 14, 2008
SURGISTOOL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FZM·July 22, 2011
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 15, 2013
ADVANTAGE FIT ULTRA SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026
DR FOG TREATED SPONGE, STERILE
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·January 20, 2021
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025