14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIGNATURE PLANNER,SIGNATURE GUIDES
FDA 510(k)
FDA Class 2
·Orthopedic
Flexitron
FDA UDI
Nucletron B.V.·08717213027046·Flexitron Transfer Tube for 4F Flexibles (12)
VCS-A SERIES CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
IT/IF CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DERMABOND ADVANCED 0.7ML - 12EA
FDA Adverse Event
Injury
·ETHICON INC.·Product code MPN·October 7, 2022
FIBULA COMP LOCK PLATE 10H STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 24, 2016
CORONOID PLATE RT STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·June 9, 2016
GUARDIAN ROLLING WALKER
FDA Adverse Event
Malfunction
·A&E·Product code ITJ·November 4, 2008
MONOPOLAR CAUTERY INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 14, 2013
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·August 13, 2008
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
S3 SHOULDER PLATE 4 HOLE RIGHT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013
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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021