11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Optilite IgM CSF Kit
FDA 510(k)
FDA Class 2
·Immunology
CONMED MACROLYTE DISPERSIVE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 1, 2024
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·October 6, 2008
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON- IRVINE TECHNOLOGY CENTER·Product code HQC·June 21, 2013
BIOFINITY (COMFILCON A)
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING, LTD.·Product code LPM·July 26, 2011
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012