10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aurora
FDA 510(k)
FDA Class 2
·Radiology
Nutraseb Facial Cream
FDA 510(k)
FDA Unclassified
·Unknown
INSCOPE 3-STAGE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·March 7, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·March 7, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·September 12, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025