8 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OvertureTi Knee Resurfacing SystemTM
FDA 510(k)
FDA Class 2
·Orthopedic
PET-DOSE
FDA 510(k)
FDA Class 2
·Radiology
G7 Finned Acetabular Shell
FDA 510(k)
FDA Class 2
·Orthopedic
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·July 23, 2013
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025