9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131331540·OPN 2, KIT 10 85 PB C001
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
FDA 510(k)
FDA Class 2
·Radiology
APEX PS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRIAGE CARDIAC PANEL KIT (25T)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·June 14, 2013
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 28, 2011
*
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 21, 2008
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·September 30, 2020
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012