8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes Retrograde Femoral Nail Advanced System
FDA 510(k)
FDA Class 2
·Orthopedic
NEODENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PERSONAL INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 2, 2011
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 16, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025