10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CALCIUM CHLORIDE (0.025M)
FDA 510(k)
FDA Class 2
·Hematology
ARTOURA Breast Tissue Expanders with Smooth Surface
FDA 510(k)
FDA Unclassified
·Unknown
STRAUMANN DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 21, 2014
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 19, 2007
PROMUS ELEMENT ¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 26, 2012
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation , Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. MERIDIAN pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, sine offering adaptive-rate therapy. MERIDIAN pacemakers use an accelerometer that allows the pacing rate to adapt to the patient's changing metabolic demand as it responds to patient activity.
FDA Recall
Terminated
·Guidant Corporation·Product code LWP·July 18, 2005