10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NicoletOne
FDA 510(k)
FDA Class 2
·Neurology
Ponto
FDA UDI
Oticon Medical AB·05712149013906·Ponto Soft band, beige
TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
FDA 510(k)
FDA Class 2
·General Hospital
RT600
FDA 510(k)
FDA Class 2
·Neurology
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·June 17, 2013
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 23, 2011
BIOSCREW XTRALOK, 9 X 35MM
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code MAI·September 22, 2008
STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM
FDA Adverse Event
Injury
·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019
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