18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
FDA 510(k)
FDA Class 2
·Radiology
PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROCALM MODEL 1 AND 2
FDA 510(k)
FDA Class 2
·Neurology
ELECTORDE PAD, SPLIT
FDA Adverse Event
Other
·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code ODR·October 6, 2008
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 20, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP·Product code DSQ·July 27, 2011
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
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 26, 2023
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
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016