8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
WIRION
FDA 510(k)
FDA Class 2
·Cardiovascular
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
FDA 510(k)
FDA Unclassified
·Unknown
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
FDA 510(k)
FDA Class 2
·Orthopedic
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY-SAN JOSE·Product code FSS·June 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014
RENAISSANCE 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 2, 2011
ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
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