7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WELCH ALLYN OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
XIA 4.5 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
StatStrip Xpress Glucose Hospital Meter System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JJE·February 8, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 22, 2014
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·November 30, 2016