10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SPENCO DERMAL PADS
FDA 510(k)
FDA Class 1
·General Hospital
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX PS KNEE SYSTEM - PS-C INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
BD SYRINGE S2 5ML 22GA 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 16, 2019
SYRINGE S2 5ML 22GA 1-1/4IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 25, 2019
TRUEBALANCE
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 24, 2014
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·October 31, 2012
HILL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 13, 2010
DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . DISCOVERY II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. DISCOVERY II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.
FDA Recall
Terminated
·Guidant Corporation·Product code LWP·July 18, 2005
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