9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Portable Oxygen Concentrator (Spirit-3)
FDA 510(k)
FDA Class 2
·Anesthesiology
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 1, 2022
CDX DIGITAL X-RAY IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
XIDF-AWS801, Angio Workstation, v5.31
FDA 510(k)
FDA Class 2
·Radiology
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 20, 2022
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
CROSSFLOW CONSOLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code HRX·November 11, 2014
TUNNELING TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025