11 results
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25ms
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Sources: EU EUDAMED, US FDA
FO96 HANDY MASSAGER
FDA 510(k)
FDA Class 1
·Physical Medicine
Brigade
FDA UDI
Nuvasive, Inc.·00887517192301·Brigade Trial, 16x38x28mm 12°
Brigade
FDA UDI
Nuvasive, Inc.·00887517391414·CoRoent XLR-F, 16x38x28mm 12°
Brigade
FDA UDI
Nuvasive, Inc.·00887517397232·CoRoent XLR-F, 16x38x28mm 12°
SINGLE BED ARRHYTHMIA MONITOR AM500
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 4, 2024
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·December 17, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 28, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·July 14, 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