7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
TRILLIUM Oval MR System
FDA 510(k)
FDA Class 2
·Radiology
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
FDA 510(k)
FDA Class 2
·Cardiovascular
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·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
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025