8 results
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25ms
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Sources: EU EUDAMED, US FDA
LIDO TM ACTIVE BACK
FDA 510(k)
FDA Class 2
·Physical Medicine
FLEXIBLE LIQUID LIGHT GUIDE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER
FDA Adverse Event
Malfunction
·MENTOR TEXAS·Product code MRD·July 5, 2023
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 19, 2014
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·October 19, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·December 22, 2012
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