11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613059040·Iris Scissors Straight, Mid-Screw To Tip 30mm, ...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0131100·Rod Inserter, Fixed, 90 Degree, MIS
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece
AXERA ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ANISEIKONIA INSPECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 14, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·January 14, 2013
ENDO ILS 25MM, CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 2, 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