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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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11 records meeting your search criteria returned- Product Code: BTO Product Problem: Gel Leak Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH 07/06/2022
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 07/22/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 06/29/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 06/28/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 06/23/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 05/20/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 04/22/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 04/15/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 04/15/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 04/11/2021
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