11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONQUEST FN
FDA 510(k)
FDA Class 2
·Orthopedic
SAIPH
FDA UDI
MATORTHO LTD·05055455506114·SAIPH Femur Cemented Blue Right Size 5
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNGO VIA MI WORKFLOWS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2024
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 5, 2011
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·June 27, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
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