9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMP MASTER, PMMA-based dental resin
FDA 510(k)
FDA Class 2
·Dental
FORZA XP Expandable Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
FDA 510(k)
FDA Class 2
·Orthopedic
BD PHOENIX¿ AST BROTH
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2023
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC·Product code NBW·November 25, 2008
MEDTRONIC NAV CD HORIZON SOLERA 4.75MM DRIVER
FDA Adverse Event
Injury
·MEDTRONIC·Product code HXX·September 6, 2011
ATTAIN ABILITY
FDA Adverse Event
Death
·MPRI·Product code OJX·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025