12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CorPath 200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
AGC KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304243033·
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
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315811430·XL CSF1R BA, 10x 100µl, Break Apart Probe
SEMPERFLO INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
TRIMOTION INJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
APOLLO GENERATOR
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code GWG·June 11, 2015
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013
ENDURANT ILIAC STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·June 17, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 8, 2014
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·November 10, 2021
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·January 15, 2026