7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIDAL DISTENSION IRRIGATION SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RESMED HOSPITAL FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
PULSE OXIMETER CMS50EW
FDA 510(k)
FDA Class 2
·Cardiovascular
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·May 30, 2014
EVLT OPS
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code GEX·October 23, 2012
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 22, 2010
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026