9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FMWAND HANDPIECE SE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FIBERLASE C02 LASER WAVEGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MYDON C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 31, 2013
SIRUS NAIL FOR FEMUR
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·June 16, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIQ·August 28, 2008
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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