8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECHELON Synergy MRI system
FDA 510(k)
FDA Class 2
·Radiology
TRX VERTICAL POSITIONER
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
FDA 510(k)
FDA Class 2
·Radiology
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 21, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026