13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lucitone Denture Base Materials
FDA 510(k)
FDA Class 2
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127834·2.4 X 22mm Cannulated Headed Screw, T7
Portex
FDA UDI
ICU MEDICAL, INC.·00351688039555·
SPACELABS MEDICAL PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
CRAG LATERAL FLOW ASSAY (LFA)
FDA 510(k)
FDA Class 2
·Microbiology
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 28, 2011
SIMILE
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EBF·June 21, 2013
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 17, 2014
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 11, 2026