8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kelowna GYN and Crook Prostate Templates
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
SPOT CHECK PULSE OXIMETER,512/513
FDA 510(k)
FDA Class 2
·Cardiovascular
PELLEFIRM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 6, 2014
PYXIS ANESTHESIA SYSTEM (PAS)
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BRY·July 22, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025