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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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8 records meeting your search criteria returned- Product Code: DWC Product Problem: Break Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
GENTHERM MEDICAL, LLC HEMOTHERM 12/21/2020
GENTHERM MEDICAL, LLC HEMOTHERM 400CE 06/05/2019
CINCINNATI SUB-ZERO PRODUCTS, LLC / GENT HEMOTHERM HEATER / COOLER - DUAL RESERVO 04/12/2019
LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T 03/15/2019
LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T 03/15/2019
LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T 03/15/2019
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO SARNS DUAL COOLER HEATER 05/17/2018
MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE 01/29/2016
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