7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MALLEABLE PENILE PROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MIMIX MP BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Neurology
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
LIST TB ULTRA WHITE FIRM PR-009305 EU
FDA Adverse Event
Malfunction
·SKILLMAN CONTRACT·Product code EFW·November 22, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 2, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·September 22, 2010
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