8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline UNITE® Digital Fusion Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
PRS Plate
FDA UDI
I.T.S. GmbH·09120034302831·PRS Plate, 4-Hole, Curved, R88
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NB3D BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·October 29, 2014
FLEXCATH STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·August 15, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025