11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
FDA 510(k)
FDA Class 2
·Neurology
iTotal® CR Tibial Keel Punch Tip
FDA UDI
Conformis, Inc.·00850268007262·iTotal® CR 10mm Tibial Keel Punch Tip Reusable ...
POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FUSION 7D
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 22, 2008
TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·November 30, 2020
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