9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smith+Nephew INTELLIO Tablet
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
FDA 510(k)
FDA Class 2
·General Hospital
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
CAPTURE-R READY INDICATOR CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·March 20, 2013
PLUS SL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPEDICS AG·Product code KWY·November 5, 2008
INTELLIVUE XDS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 17, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025