13 results
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19ms
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Sources: EU EUDAMED, US FDA
TEPHAFLEX BRAIDED SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565334·CoRoent Ant TLIF PEEK, 13x12x34mm 8°
AGXO
FDA UDI
Oticon A/S·05707131258908·H150, MINIRITE 312 WL CBE AGXO
KAYE NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896022065·KAYE NEEDLE HOLDER TUNGSTEN CARBIDE TIP
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
FDA 510(k)
FDA Class 2
·Orthopedic
31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NIK·October 1, 2014
REVEL
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·May 1, 2013
RF MULTIGEN
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·June 13, 2011
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
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