7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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B-D ULTRA FINE(R) LANCET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOSFET AUTOSENSE WIRELESS
FDA 510(k)
FDA Class 2
·Radiology
JUVORA DENTQAL DISC
FDA 510(k)
FDA Class 2
·Dental
REACH ACCESS DAILY FLOSSER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·January 29, 2013
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC LP·Product code FNL·November 30, 2010
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·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