11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUXILIARY INSTRUMENTS FOR URS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293388·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690191735·Tibia Tray Inserter Assembly
Advanced RBC Application
FDA 510(k)
FDA Class 2
·Hematology
SPECTRO-SUR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 14MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code OVE·February 21, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 26, 2011
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 31, 2014
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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