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U.S. Department of Health and Human Services

Medical Device Recalls
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41 to 50 of 243 Results
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myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure man... 2 11/22/2019 ENDOTRONIX
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhan... 2 11/13/2019 Carroll-Baccari, Inc.
Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance... 2 11/13/2019 Carroll-Baccari, Inc.
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Singl... 2 09/09/2019 Philips North America, LLC
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightw... 2 09/06/2019 Philips North America, LLC
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARV... 2 07/25/2019 Bard Peripheral Vascular Inc
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to def... 2 07/03/2019 ZOLL Medical Corporation
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patie... 2 10/11/2018 Edan Diagnostics
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
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