8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AI-Rad Companion (Pulmonary)
FDA 510(k)
FDA Class 2
·Radiology
PELVIC ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 12, 2024
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JGS·September 3, 2011
VIKING
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025