11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nexis osteosynthesis compressive screws
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814251·GENUMEDI PT SILVER R II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814176·GENUMEDI PT SILVER R I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814268·GENUMEDI PT SILVER R III
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GAT·October 15, 2024
MODIFICATION TO ALTIUS OCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTETRAK
FDA Adverse Event
Other
·EXACTECH INC.·Product code HSH·May 28, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 22, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 28, 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