7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
Intravascular Extension Sets and Accessories
FDA 510(k)
FDA Class 2
·General Hospital
CMF CUSTOMIZED IMPLANT KIT LARGE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KKY·March 7, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 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