8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ameda Pearl Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
FDA 510(k)
FDA Class 2
·Anesthesiology
IMMULITE 2000 ANTI-CCP IGG ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ACTIS COLLARED STD SIZE 5
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code MEH·December 18, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 3, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 18, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025