17 results
·
30ms
·
Sources: EU EUDAMED, US FDA
C-PET PLUS IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042839·ARM CARE CCL.1, SIZE S, NATUR, GRADUATED COMPRE...
SAMPLE CUPS, 0.5 ML
FDA Adverse Event
BECKMAN COULTER, INC.·Product code NNI·October 6, 2011
AUROPAL, ORDER-NO.: 2101
FDA 510(k)
FDA Class 2
·Dental
END EXPIRATORY FILTER, MODEL RT020
FDA 510(k)
FDA Class 2
·Anesthesiology
BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·December 20, 2019
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·December 9, 2019
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·December 23, 2019
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·December 27, 2019
SAMPLE CUPS, 0.5 ML
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code NNI·January 12, 2012
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code KDI·April 4, 2013
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·March 30, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·June 4, 2020
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013