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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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10 records meeting your search criteria returned- Product Code: BTM Product Problem: Gas/Air Leak Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
SUNMED HOLDINGS LLC SUNMED LLC 09/21/2023
SUNMED HOLDINGS, LLC VENTLAB 05/25/2023
WESTMED, INC. BAGEASY 04/10/2023
WESTMED, INC. BAGEASY RESUSCITATOR 04/03/2023
AMBU A/S SPUR II INFANT 11/04/2022
SUNMED LLC SUNMED HOLDINGS LLC 03/30/2022
AMBU A/S SPUR II PEDI. BAG RESVR 06/11/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 05/14/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PEDIATRIC 1ST RESPONSE MANUAL RESUSCITAT 05/13/2021
Unknown Manufacturer PNEUPAC VENTILATOR 04/19/2021
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