8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
RESI-WALKER
FDA 510(k)
FDA Class 1
·Physical Medicine
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788231050·Long Handle Curette #4 Rev Ang
ATAC CALCIUM REAGENT AND ATAC CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XGEO GU60
FDA 510(k)
FDA Class 2
·Radiology
BATTERY 14.8V, 6.3 AH LI-ION BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 30, 2014
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·November 7, 2012
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·September 1, 2010
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011