15 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
5.0MM TI SIDE-OPENING SCREW 40MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
5.0MM TI SIDE-OPENING SCREW 40MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012
IS 3800 I/O 3D SCANNER
FDA UDI
Dental Imaging Technologies Corporation·00693856000043·IS 3800
CS 3800 Wired
FDA UDI
CARESTREAM DENTAL LLC·60192155943720·CS 3800 3D I/O SCANNER WIRED
Alexander SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007596·LO2BI UNV -17T 0A .018 (PK10)
Consensus Knee System Modular Tibial Baseplate
FDA 510(k)
FDA Class 2
·Orthopedic
BD Vaginal Panel
FDA 510(k)
FDA Class 2
·Microbiology
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·January 5, 2016
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·December 16, 2010
HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY·Product code LFL·January 23, 2013
AQUAMANTYS BIPOLAR SEALER
FDA Adverse Event
Injury
·MEDTRONIC ADVANCED ENERGY, LLC·Product code DWG·July 18, 2014
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