8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MediRod Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDLINE STRIDER MIDI 4
FDA 510(k)
FDA Class 2
·Physical Medicine
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
ENDO GIA
FDA Adverse Event
Malfunction
·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GDW·November 17, 2008
TVL LEAD, RIGHT VENTRICULAR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025