8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitreq disposable laser probes, light fibers and Chandelier
FDA 510(k)
FDA Class 2
·Ophthalmic
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331170324·russian tissue forceps, 14" (35.5 cm)
SPIDER FLEX MONOPOLAR HOOK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 11, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·July 4, 2011
PLAYTEX, GENTLE GLIDE, SUPER, UNSCENTED TAMPONS
FDA Adverse Event
Malfunction
·PLAYTEX PRODUCTS, INC.·Product code HEB·September 24, 2008
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