20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Laser Peripherals, LLC Family of Bare Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNGO.CT CARDIAC FUNCTION
FDA 510(k)
FDA Class 2
·Radiology
MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 4, 2020
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 15, 2020
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 20, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 24, 2013
TS FLEX ARTICNG LNR CUTR 45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 12, 2008
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 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
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JJE·April 3, 2025
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023