8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE
FDA 510(k)
FDA Class 2
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123014·K-WIRE - SINGLE TROCAR 2.0mm DIA x 150mm
SINGLE USE LEE ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXULT Knee Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·February 4, 2013
DRILL BIT MINI; DRILL BIT SHORT
FDA Adverse Event
Malfunction
·ORTHO DEVELOPMENT CORP.·Product code HTW·November 9, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 5, 2014
Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).
FDA Recall
Terminated
·Radiometer America Inc·Product code JFP·April 7, 2011