9 results
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18ms
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Sources: EU EUDAMED, US FDA
OCULAR INFUSION CANNULA SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Printed Lower Crown Pack for Herbst LL7 10mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199016180·
NA
FDA UDI
Stryker GmbH·04546540369109·Plastic Base Case
Nalu Neurostimulation SCS system
FDA 510(k)
FDA Class 2
·Neurology
VITOMATRIX
FDA 510(k)
FDA Class 2
·Dental
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 30, 2014
UNKNOWN DEPUY TIBAL TRAY
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·January 8, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 12, 2010
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