8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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308nm Excimer System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AQUILEX FLUID CONTROL SYSTEM H112
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
FDA 510(k)
FDA Class 2
·Radiology
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
RESOLUTE INTEGRITY OTW
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·June 27, 2013
ENDOTAK DSP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·August 5, 2011