9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Delphi Amplifier
FDA 510(k)
FDA Class 2
·Neurology
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369856·Trial, Size 12x14x10 mm, 20°
Digital thermometer, Model DT101, DT102
FDA 510(k)
FDA Class 2
·General Hospital
Venen-trainer (Model: FM150, SFM90)
FDA 510(k)
FDA Class 2
·Cardiovascular
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 11, 2014
5855 ORTHOPEDIC TABLE TOP
FDA Adverse Event
Malfunction
·MIZUHO OSI·Product code JEA·July 29, 2011
TAPER SLEEVE ADAPTER 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code JDI·July 23, 2013
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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025