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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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7 records meeting your search criteria returned- Product Code: BTO Product Problem: Material Twisted/Bent Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
SMITHS MEDICAL ASD, INC. TRACHEOSTOMY/PVC PORTEX TUBES- BLUSELECT 10/31/2022
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX EPIDURAL MINIPACKS 08/29/2022
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CONTINUOUS CAUDAL PEDIATRIC EPIDU 08/29/2022
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEOSTOMY TUBE 08/29/2022
NULL TRACHEOSTOMY TUBE 11/13/2021
SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX 03/02/2021
SMITHS MEDICAL ASD, INC. PORTEX UNIPERC INNER CANNULAE 04/18/2019
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