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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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50 records meeting your search criteria returned- Product Code: BTL Product Problem: Leak/Splash Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS 08/24/2022
FISHER & PAYKEL HEALTHCARE LTD NEOPUFF INFANT RESUSCITATOR 07/11/2022
NULL PORTEX TUBES BLUSELECT 05/19/2022
SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC VENTILATOR 02/22/2022
ST PAUL PNEUPAC VENTILATORS PARAPAC 01/26/2022
NULL PORTEX GENERAL ANESTHESIA BAGS 12/15/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC 11/13/2021
FISHER & PAYKEL HEALTHCARE LTD NEOPUFF INFANT RESUSCITATOR 10/28/2021
Unknown Manufacturer NEOPUFF INFANT RESUSCITATOR 09/15/2021
Unknown Manufacturer PNEUPAC 04/09/2021
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