12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MAXIMUS OS (OVERDENTURE SYSTEM)
FDA 510(k)
FDA Class 2
·Dental
OIL FOR EMBRYO CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VECTOR TARGETING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
PERF CONS TIB INLAY 15MM S
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·April 9, 2013
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Injury
·INVACARE·Product code FNL·March 29, 2011
VITALITY 2 DR EL
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
PRISMAFLEX SETS (HF)
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 22, 2023
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·October 31, 2023
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018