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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Electric Wheelchair (LW01301A07)
FDA 510(k)
FDA Class 2
·Physical Medicine
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
SOFIA 6F Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
IMAGENPRO
FDA 510(k)
FDA Class 2
·Radiology
HEARTMATE XVE LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 3, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 15, 2011
NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code FYD·July 26, 2013
TRANSMITTER MMT-7841ZW GST5G OUS
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PQF·September 2, 2025
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024