7 results
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20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BASE METAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
MULTI-CHEM CALIBRATOR A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QANS (Quantitative Autonomic Nervous System) Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·February 21, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 21, 2012
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 23, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018