8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
FDA 510(k)
FDA Class 1
·Dental
VuePoint
FDA UDI
Nuvasive, Inc.·00887517181145·VuePoint Screw, 3.5x42mm Fav Angle MA
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHILIPS INTEGRIS C2000 SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DEPUY ASR FEM IMPLANT SZ53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KXA·November 19, 2010
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 9, 2013
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 1, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021