8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PUMP MODULES PMO LO-110-PMD 10-210
FDA 510(k)
FDA Class 2
·Cardiovascular
GETINGE 400HC-E / SERIES STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·May 20, 2014
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 9, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 22, 2010
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025