8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FilmArray Warrior Control Panel M290
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
SEDECAL
FDA 510(k)
FDA Class 2
·Radiology
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
PULSE GEN MODEL 104
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·October 10, 2014
MEDTRONIC PARADIGM INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC·Product code MDS·June 19, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024