7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANTHRO-MODULAR TOTAL KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
CENTRAL STATION 590
FDA 510(k)
FDA Class 2
·Cardiovascular
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO
FDA 510(k)
FDA Class 2
·Anesthesiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 28, 2014
DOUBLEAIRHOSE L5M F/SYST DRÄGER
FDA Adverse Event
Injury
·SYNTHES·Product code HWE·November 15, 2012
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·September 10, 2010
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019