10 results
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21ms
·
Sources: EU EUDAMED, US FDA
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925016729·CAWTHORNE SCISSOR,FINE, STRAIGHT,3 X .8MM
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·December 4, 2019
TELZUIT CARDIAC MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 11, 2022
AESTIVA
FDA Adverse Event
Malfunction
·DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C·Product code BSZ·May 23, 2013
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·September 29, 2014
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
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