12 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111085543·LOVELACE HEMO FCP SERR 6 1/4"
Accent 1000 Keyguard 8 Location
FDA UDI
PRENTKE ROMICH COMPANY·00858526006378·Keyguards are made from thick, clear polycarbon...
VIEWPOINT 6
FDA 510(k)
FDA Class 2
·Radiology
BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
FDA 510(k)
FDA Class 2
·Dental
REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 16, 2021
REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 6, 2019
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCE
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·October 10, 2014
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code MND·June 6, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2011
CANNULATED CRUCIFORM SCREWDRIVER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·May 13, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021