7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FDTENS 2010
FDA 510(k)
FDA Class 2
·Neurology
AUTODERM SCANNER CONTROL CONSOLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICRO-X 30 HF
FDA 510(k)
FDA Class 1
·Radiology
ACCESS
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·March 8, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·July 23, 2014
MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC·Product code FOZ·January 14, 2011
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