7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biophotas Celluma CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Alinity m STI Assay
FDA 510(k)
FDA Class 2
·Microbiology
JMS BYPASS TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 6, 2014
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·July 22, 2011
INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025