7 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES BUTTON PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)
FDA 510(k)
FDA Class 2
·Immunology
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 12, 2015
V.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·March 5, 2013
PARAGON T2 WITH INTEGRATED CABLE
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·July 23, 2014
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