7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED INSTAFIL
FDA 510(k)
FDA Class 2
·General Hospital
SPIRA-C Open Matrix Cervical Interbody
FDA 510(k)
FDA Class 2
·Orthopedic
MOBIL-O-GRAPH NG 24 H ABP-CONTROL
FDA 510(k)
FDA Class 2
·Cardiovascular
ION?
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 13, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 12, 2010
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 13, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015