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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 Flex Analyzer Model Numbers 393-800 and 393-801 2 07/01/2022 Radiometer Medical ApS
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)0570069... 2 07/04/2020 Radiometer Medical ApS
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)0570069... 2 07/04/2020 Radiometer Medical ApS
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 2 05/01/2020 Radiometer Medical ApS
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the param... 2 04/08/2020 Radiometer Medical ApS
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
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