9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InMode RF Pro System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Smith & Nephew, Inc.·00885554011098·MTO ENDO-FEMORAL GUIDE 2MM OFFSET
K2 MEDICAL VASCULAR CLAMPS
FDA 510(k)
FDA Class 2
·Cardiovascular
i-STAT CG4+ Cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 29, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·Product code KWA·August 9, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
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