9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
7250 (MEGAS)
FDA 510(k)
FDA Class 2
·Radiology
APDYNE PHENOL APPLICATOR KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
QUALTEX MAGNETIC INSTRUMENT DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·August 30, 2012
TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DRC·March 5, 2013
PUMP IN STYLE ADVANCED
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·January 14, 2011
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 8, 2014
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR, PRIMING VOLUME 0.11 ML
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·October 13, 2023
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