8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
AUDIT TM V
FDA 510(k)
FDA Class 2
·Neurology
BEL BLOOD LEVEL DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
WasherCap Mini Fixation System (Model 45)
FDA 510(k)
FDA Class 2
·Orthopedic
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 12, 2014
SIMPULSE
FDA Adverse Event
Malfunction
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FQH·October 26, 2012
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FMF·September 21, 2010
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
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