10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HU-FRIEDY IMS CASSETTE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
E-LINE
FDA UDI
Richard Wolf GmbH·04055207010228·COAG ELECTRODE MONO 24FR 25° for long shaft re...
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8440021·The DD cubeY® HL zirconium dioxide milling blan...
LYSINE IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
AngioWaveNet
FDA 510(k)
FDA Class 2
·Radiology
ASSURITY MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·September 2, 2025
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 2, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 23, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
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