8 results
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25ms
·
Sources: EU EUDAMED, US FDA
PETRUS SINGLE MIRROR LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Contact Lens Case
FDA 510(k)
FDA Class 2
·Ophthalmic
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 19, 2014
SPRINT FIDELIS
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010
UNKNOWN DEPUY ASR ADAPTER SLEEVE
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 10, 2012
UNK - SYNFLATE/VBS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NDN·October 22, 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