7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAUMAN CPR/RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
D88VS WHEELCHAIR POWER SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
UNKNOWN HIP NAIL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·August 8, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·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