8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Micro C Medical Imaging System, M01
FDA 510(k)
FDA Class 2
·Radiology
DEKA SMARTPERIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ILS·November 11, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 23, 2013
DEKA SMARTPERIO
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025