7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Revolution Maxima, Revolution Ace
FDA 510(k)
FDA Class 2
·Radiology
ABL90 FLEX SERIES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 7, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
FDA Recall
Terminated
·Radiometer America Inc·Product code CEM·January 12, 2011