9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Quality Mix Blender, Oxymixer
FDA 510(k)
FDA Class 2
·Anesthesiology
GDC POWER SUPPLY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
FDA 510(k)
FDA Class 2
·Neurology
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
FDA 510(k)
FDA Class 2
·Orthopedic
CAPTURE-R READY-ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·November 3, 2015
ELECSYS 2010 RACK
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 5, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·August 24, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORP·Product code MVK·July 2, 2013
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025