9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MALLEABLE SUCTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
VENUS FLOW
FDA 510(k)
FDA Class 2
·Dental
CERTAIN GOLD-TITE TM HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·August 26, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 12, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025