7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SPEC 5* SUPRAPUBIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cook Cystostomy Catheter Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 7, 2014
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·October 20, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026