7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CIT GRASPING AND DISSECTING FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NEUROSEARCH-24 OR NRS-24
FDA 510(k)
FDA Class 2
·Neurology
MODEL 483-02 PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2010
PROXIMATE** LINEAR CUTTER RELOAD - STANDARD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 5, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 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