8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SyMRI
FDA 510(k)
FDA Class 2
·Radiology
WINSIX Implant System
FDA 510(k)
FDA Class 2
·Dental
12MP Color Digital Mammography LCD Monitor CL-S1200
FDA 510(k)
FDA Class 2
·Radiology
DENTAL SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·April 14, 2026
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014
COULTER® HMX HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 3, 2011
XIA 3 TITANIUM TORQUE WRENCH
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025