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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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9 records meeting your search criteria returned- Product Code: BTT Product Problem: Failure of Device to Self-Test Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCU 07/03/2022
FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCU 03/03/2022
FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER 01/19/2022
Unknown Manufacturer VENTED HUMIDIFICATION CHAMBER 05/25/2021
Unknown Manufacturer VENTED HUMIDIFICATION CHAMBER 04/29/2021
Unknown Manufacturer ADULT INSPIRATORY HEATED BREATHING CIRCU 04/21/2021
FISHER & PAYKEL HEALTHCARE LTD VENTED AUTOFEED HUMIDIFICATION CHAMBER 01/07/2021
Unknown Manufacturer ADULT DUAL HEATED BREATHING CIRCUIT 07/23/2020
Unknown Manufacturer HEATED OXYGEN THERAPY KIT 12/28/2019
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