7 results
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28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Contour Knee
FDA 510(k)
FDA Class 2
·Radiology
OLYMPUS ENERGY POWER SYSTEM (EPS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
FDA 510(k)
FDA Class 2
·Cardiovascular
CELL-DYN RUBY ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 25, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 4, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 12, 2013
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026