11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JARIT HULKA UTERINE TENACULUM FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
METAVISION CLINICAL INFORMATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PLACER
FDA 510(k)
FDA Class 2
·Neurology
STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
FDA Adverse Event
Other
·SORIN GROUP, DEUTSCHLAND·Product code DXC·April 15, 2010
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 3, 2021
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 16, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 9, 2011
CUSTOM DEFINED TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·July 24, 2008
1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code DZI·May 19, 2015
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