10 results
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18ms
·
Sources: EU EUDAMED, US FDA
P.F.C. CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123014·K-WIRE - SINGLE TROCAR 2.0mm DIA x 150mm
Membrane for E733 electrode
FDA UDI
Radiometer Medical ApS·05700699420602·D733 Ca membrane box (4units) for ABL7XX/8XX
TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 6, 2012
TRANSOM ANTERIOR CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·February 4, 2013
MICRBR GEMSTR .2 FLTR PP Y-SITE 96IN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·November 9, 2010
9900
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