17 results · 30ms · Sources: EU EUDAMED, US FDA

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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