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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 18 Results
510(K) Number: K052601
 
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LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate w... 2 03/13/2020 LivaNova USA Inc.
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St®ckert Heat... 2 10/25/2019 LivaNova USA Inc.
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart... 2 04/06/2019 LivaNova USA Inc.
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82... 2 05/18/2018 LivaNova USA
STOCKERT Heater-Cooler System 3T, 230 V 2 07/25/2017 Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz 2 07/25/2017 Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz 2 07/25/2017 Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz 2 07/25/2017 Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz 2 07/25/2017 Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz 2 07/25/2017 Sorin Group USA, Inc.
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