8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EMPOWR Revision Knee
FDA 510(k)
FDA Class 2
·Orthopedic
RithmID-SD Steerable Diagnostic Electrophysiology Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
KENTROX SL-S 65/16 STEROID
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO, KG·Product code LWS·July 29, 2011
ENDO GIA
FDA Adverse Event
Malfunction
·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GDW·November 18, 2008
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code JDI·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025