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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 21 Results
510(K) Number: K041874
 
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ABL800 analyzer, model numbers 393-800 and 393-801. 2 12/22/2018 Radiometer America Inc
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood... 2 12/08/2017 Radiometer America Inc
The ABL800 Model#:All 2 03/14/2017 Radiometer America Inc
ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device) 2 06/25/2015 Radiometer America Inc
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-... 2 02/24/2014 Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the... 2 08/08/2012 Radiometer America Inc
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro t... 2 08/08/2012 Radiometer America Inc
Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste bottles are ... 2 07/15/2009 Radiometer America Inc
Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on... 2 10/11/2007 Radiometer America Inc
ABL 800 FLEX series blood gas analyzers containing software version 5.24. 3 07/24/2007 Radiometer America Inc
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