8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ASCENT KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
THORACENTISIS KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DE-TOX TUBES A AND DE-TOX TUBES B
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·August 30, 2012
GUARDIAN II NC HEMOSTASIS VALVE
FDA Adverse Event
Injury
·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013
GMK FEMORAL CUTTING GUIDE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·January 14, 2011
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·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