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U.S. Department of Health and Human Services

Medical Device Recalls

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71 to 80 of 243 Results
Product: ecg
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ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smar... 2 10/12/2011 Edan Instruments, Inc.
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure man... 2 11/22/2019 ENDOTRONIX
Esaote brand ArchiWin Colour ECG System; part 9704325000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand Formula for Archimed ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand Formul@ ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand Archimed 4220 ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Densh... 2 12/06/2017 Fukuda Denshi Co., Ltd.
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) co... 2 10/10/2018 GE Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(... 2 10/10/2018 GE Healthcare Finland Oy
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress... 2 06/22/2021 GE Healthcare, LLC
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