11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIONECT CLEAR HYDROGEL
FDA 510(k)
FDA Unclassified
·Unknown
MULTICHEM CREATININE REAGENT S0917
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NeuMoDx GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
ASR ACETABULAR IMPLANT 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 17, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
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
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