10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
FDA 510(k)
FDA Class 1
·Hematology
25GA Curved Illuminating Probe, SMA905
FDA UDI
Peregrine Surgical, Llc·00632307001925·25GA Curved Illuminating Probe, SMA905
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103400·
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
STERIS AMSCO MILLENNIUM STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
VELA XL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·March 24, 2025
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 8, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 5, 2011
DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
FDA Adverse Event
Injury
·CARDIOVASCULAR SYSTEMS, INC.·Product code MCW·May 7, 2008
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