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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
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76 records meeting your search criteria returned- Product Code: DTZ Product Problem: Improper Flow or Infusion Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
TERUMO MEDICAL CORPORATION CAPIOX RX OXYGENATOR 06/01/2023
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO STERILE FX25RWC W/ RES 04/10/2023
TERUMO CARDIOVASCULAR SYSTEMS CORPORATIO NS FX15REC W/4L RES 05/19/2022
CARDIACASSIST INC. TANDEMLUNG OXYGENATOR 09/06/2021
MAQUET CARDIOPULMONARY GMBH OXYGENATOR 08/19/2021
LIVANOVA DEUTSCHLAND TANDEMLUNG OXYGENATOR 08/05/2021
Unknown Manufacturer TUBING SET 04/14/2021
MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 04/14/2021
CARDIACASSIST INC. TANDEMLUNG OXYGENATOR 03/26/2021
PERFUSION SYSTEMS AFFINITY PIXIE HFO AND PIXIE CVR 12/22/2020
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