9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Plenity
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
FDA 510(k)
FDA Class 2
·Microbiology
QMS Plazomicin Immunoassay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code QIJ·July 28, 2023
ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
FDA Adverse Event
Malfunction
·COOK MEDICAL IRELAND·Product code QIJ·July 11, 2024
DUETTE MULTI-BAND MUCOSECTOMY DEVICE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code KNS·October 24, 2023
ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code QIJ·January 27, 2022
ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code QIJ·November 3, 2021
ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code QIJ·May 27, 2024