8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPARK Scan
FDA 510(k)
FDA Class 2
·Neurology
LAG SCREW, TI GAMMA3 10.5X95MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 25, 2012
ENDOMAT LC PUMP, MODEL 20 3303 20
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FETAL ULTRASONIC MONITOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022