8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICOT STEAM TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135479·
MODEL U-1000 ULTRASONIC SCANNER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DATA ZYME ACID PHOSPHATASE PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·May 28, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code NEK·November 27, 2012
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