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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: NNX Product Problem: Inadequacy of Device Shape and/or Size Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
C.R. BARD INC. (COVINGTON) -1018233 SPIRIT® HYDROCOLLOID ADHESIVE SHEATH 05/22/2023
C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL C 04/21/2022
C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT® HYDROCOLLOID ADHESIVE SHEATH 03/29/2022
C.R. BARD, INC. (COVINGTON) -1018233 ULTRAFLEX¿ SELF-ADHERING MALE EXTERNAL C 11/11/2021
C.R. BARD, INC. (COVINGTON) -1018233 NATURAL NON-ADHESIVE MALE EXTERNAL CATHE 09/02/2020
C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STAN 03/12/2020
C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC ULTRAFLEX M 30BX 03/09/2020
C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 03/18/2019
C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDE 11/03/2017
C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STAN 11/03/2017
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