16 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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BIOMET MICROFIXATION NEURO PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GWO·April 16, 2018
TASMIN R 12°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014998·The basic shape of the TASMIN R devices is a ho...
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176148377·DIADOSS cutter
Cup Forceps
FDA UDI
ELLIQUENCE, LLC·00846338002374·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365115363·
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k)
FDA Class 2
·Immunology
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
REYNOSA MANUFACTURING·Product code FKX·May 16, 2013
UNKNOWN DEPUY PFC 48-52X28MM 10D LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 2, 2011
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 14, 2019
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 14, 2019
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