13 results
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19ms
·
Sources: EU EUDAMED, US FDA
MX-7000 MICROXEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexitron
FDA UDI
Nucletron B.V.·08717213026766·Flexitron Transfer Tube for Metal Needles (24)
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 29, 2024
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
FDA 510(k)
FDA Class 2
·Hematology
DRIVER; SIZE 10
FDA Adverse Event
Malfunction
·K2M, INC.·Product code LXH·July 12, 2022
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·May 14, 2013
ECHELON*FLEX60 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 2, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·August 13, 2008
BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 26, 2023
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
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025