7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WM. HARVEY OVERPRESSURE SAFETY VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
True Tulip, True M.I.S.
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014
LCS COMP RP INSERT STD 15MM
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code NJL·November 6, 2012
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·June 4, 2015
NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015