12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MTD 4000
FDA 510(k)
FDA Class 2
·Physical Medicine
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122186·KWire .035x6" (0.9x150mm)
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122179·KWire .035x6" (0.9x150mm) Threaded
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450272251·
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
FDA 510(k)
FDA Class 2
·Cardiovascular
RUSCH EDGAR TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025
WALLFLEX ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
PFC*SIGMA/RD/DOME PAT 3PEG,32
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code JWH·September 16, 2014
CAPD DISCONNECT Y SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 17, 2011
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018