10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLIZ LTB-1000A
FDA 510(k)
FDA Class 2
·Physical Medicine
Stealthstation S8 Spine Software v1.3.0
FDA 510(k)
FDA Class 2
·Neurology
FibroLux
FDA 510(k)
FDA Class 2
·Physical Medicine
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·November 3, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 11, 2013
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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