8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CANDIDA IMMUNODIFFUSION KIT #CA1001
FDA 510(k)
FDA Class 2
·Microbiology
VINYL POWDER FREE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
FDA 510(k)
FDA Class 2
·Dental
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code MDS·May 5, 2014
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 15, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 5, 2026
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025