26 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
FDA 510(k)
FDA Class 2
·Dental
Reveal
FDA UDI
Oticon A/S·05707131342041·G10, BTE 13 PP 2.4G 105 C092 REVEAL
ORTHO-1(NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
GAMMA3 AND T2 RECON TARGETING DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·October 22, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 12, 2025
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·October 7, 2008
ITREL 3
FDA Adverse Event
Malfunction
·MDT PUERTO RIO OPERATIONS CO., MED REL·Product code LGW·July 13, 2011
ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 27, 2013
CARDIOCHEK PLUS ANALYZERQ
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·August 18, 2022
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·July 28, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·May 24, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 6, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 11, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·November 21, 2023
OMNIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 14, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 24, 2023