7 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A-LYTE® Integrated Multisensor (IMT Na K Cl)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HAMILTON-MR1
FDA 510(k)
FDA Class 2
·Anesthesiology
Ensure Single-Use Coagulation Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTAL HIP BALL 28MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 4, 2008
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 14, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025