8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VLC GLASS IONOMER
FDA 510(k)
FDA Class 2
·Dental
MAMMOGRAPHIC KVP METER MODEL 232
FDA 510(k)
FDA Class 2
·Radiology
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·January 20, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 1, 2014
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025