8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FOREARM-CANE
FDA 510(k)
FDA Class 1
·Physical Medicine
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
Elos Accurate® Customized Abutment
FDA 510(k)
FDA Class 2
·Dental
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, INC., A ST. JUDE MEDICAL CO.·Product code OAD·August 6, 2010
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018