12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
FDA 510(k)
FDA Class 2
·Radiology
ACTIHEART
FDA 510(k)
FDA Class 2
·Neurology
VANTAGE TITAN 3T
FDA 510(k)
FDA Class 2
·Radiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 6, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 7, 2013
LSLF EXT SET W CLV
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPK·June 27, 2011
BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·January 10, 2022
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021
DIDECO EOS ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021
SORIN LIFEKIT D905 EOS ECMO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021
EOS PMP, EOS PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023