8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vivatmo pro
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HEMOSIL LIQUID ANTITHROMBIN XL
FDA 510(k)
FDA Class 2
·Hematology
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
FDA 510(k)
FDA Unclassified
·Unknown
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE ? MOUNTAIN HOME·Product code FKX·September 3, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 6, 2014
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025