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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Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Medos International Sàrl·10886705011261·FULLY FLUTED REAMER, STERILE 40 - 130mm (Plus o...
BrainInsight
FDA 510(k)
FDA Class 2
·Radiology
OSSDSIGN Cranial PSI
FDA 510(k)
FDA Class 2
·Neurology
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code HAW·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
2520274-2013-04431
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 18, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025