9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOOPANG
FDA 510(k)
FDA Class 2
·Neurology
HQ-Chex
FDA UDI
STRECK, INC.·00844509001706·A whole blood glucose and hemoglobin control de...
NOBELPROCERA OVERDENTURE BAR
FDA 510(k)
FDA Class 2
·Dental
BEDSIDE MONITOR, MODEL OPV-1500
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 27, 2023
RF ABLATION SYSTEM FOOT SWITCH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC, EP TECHNOLOGIES·Product code LPB·November 14, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 19, 2011
METRX
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·July 18, 2013
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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