19 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEM-6410T-ZL Wrist Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
PACEART OPTIMA SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026
KIMBERLY CLARK MIC GASTROSTOMY TUBES
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code KNT·October 3, 2008
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 26, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 29, 2011
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
REZUM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019
INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025
BD MAX¿ CPO
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025