9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bipolar applicator CELON ProCurve V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020604·25g RW x 3.5" Coudé® Blunt Nerve Block Needle w...
GENESIS REUSABLE RIGID CONTAINER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
DATASCOPE MR MONITOR
FDA Adverse Event
Malfunction
·DATASCOPE CORP./PT MONITORING DIVISION·Product code MHX·January 23, 2003
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 17, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 23, 2008
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