8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
REDUCTION FORCEPS WITH POINTS BROAD-RATCHET
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·June 30, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 12, 2015
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 8, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 8, 2014