7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELTA
FDA 510(k)
FDA Class 2
·General Hospital
ENDOSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·January 31, 2013
TECNIS MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·January 3, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·July 18, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021