7 results
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18ms
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Sources: EU EUDAMED, US FDA
RPMI-1640 MEDIUM, CATALOG NO. 200-2076
FDA 510(k)
FDA Class 1
·Hematology
IMAGESVR PACS
FDA 510(k)
FDA Class 2
·Radiology
Aspida® Anterior Lumbar Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2014
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2015
EDM LUMBAR CATHETER, 80CM, BARIUM IMPREGNATED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·October 13, 2010
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is experienced in the operation of this or similar equipment. The roller pump is used to move fluids through the cardiopulmonary bypass circuit and can be used for a number of applicatinos including arterial blood pumping, cardioplegia delivery, suction, and venting.
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·February 19, 2020