15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sterile Hypodermic Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO GLOBALCARDIO
FDA 510(k)
FDA Class 2
·Cardiovascular
GRINDGUARD
FDA 510(k)
FDA Unclassified
·Unknown
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 8, 2025
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025
AGILE ESOPHAGEAL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025
AGILE ESOPHAGEAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·July 26, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·July 9, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025