8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
GEMINI
FDA Adverse Event
Other
·MEDLINE·Product code FRG·November 10, 2014
NEUROSPECTQUAD GAMMA CAMERA
FDA 510(k)
FDA Class 2
·Radiology
GEMINI STERILZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·May 14, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 14, 2013
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 11, 2010
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