7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
X-Smart Pro; X-Smart Pro+
FDA 510(k)
FDA Class 1
·Dental
ASAHI GAIA FIRST, SECOND, THIRD
FDA 510(k)
FDA Class 2
·Cardiovascular
IDEIA PCE CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
NCB PLATE FOR FEMUR, RIGHT, 13 HOLES
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·November 13, 2008
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 5, 2011
ARIZANT BAIR HUGGER WARMING UNIT
FDA Adverse Event
Malfunction
·ARIZANT HEALTHCARE INC.·Product code DWJ·July 12, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025