12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OVENT
FDA 510(k)
FDA Class 2
·Dental
Vermed
FDA UDI
GRAPHIC CONTROLS ACQUISITION CORP·00009336000104·Electrocardiographic recording paper
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 5, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
GORE DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·October 10, 2014
EON MINI IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 16, 2011
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2013
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023