8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Everyway Analog OTC TENS, model N103A/N302
FDA 510(k)
FDA Class 2
·Neurology
AERONEB GO NEBULIZER, MODEL AG-AG2000
FDA 510(k)
FDA Class 2
·Anesthesiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·August 18, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 18, 2013
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020