11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURSHIELD SAFETY I.V. CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
MODIFICATION TO VASCULAR CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
FDA 510(k)
FDA Class 2
·Orthopedic
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 14, 2023
2.4MM VA LOCKING SCREW STARDRIVE 16MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 9, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 24, 2008
HEARTMATE 3 VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·September 14, 2023
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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