12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Silver Alginate Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 23, 2026
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·April 3, 2025
MICROWAVE TREATMENT FOR BPH
FDA Adverse Event
Injury
·Product code MEQ·November 3, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
MICROLET®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code QRL·July 1, 2025
MICROLET®
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code QRL·December 1, 2023
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015