8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Small Field Applicator
FDA 510(k)
FDA Class 2
·Radiology
CarboClear® Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ELECSYS PROBNP CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 23, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 29, 2008
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - DEERFIELD·Product code FKX·July 11, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025