10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM Cima.X
FDA 510(k)
FDA Class 2
·Radiology
MyCRO Band
FDA 510(k)
FDA Class 2
·Neurology
icotec Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·June 8, 2021
ZILVER 635 SELF-EXPANDING VASCULAR STENT
FDA Adverse Event
Injury
·COOK, INC.·Product code NIO·November 14, 2008
SIMPLEX P FULL DOSE 1 PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·July 22, 2011
CHARGING SYS
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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