11 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
MOTO Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
SYNGO VIA MI WORKFLOWS
FDA 510(k)
FDA Class 2
·Radiology
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 3, 2008
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 21, 2013
75MM SELECTABLE NEW TLC
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011
OXFORD UNI FEMORAL MD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 2, 2019
OXFORD UNI TIB TRAY 44X28 LLRM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 2, 2019
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