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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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151 records meeting your search criteria returned- Product Code: EXB Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
HOLLISTER INCORPORATED NEW IMAGE FLEXTEND PRE SIZED BARRIER 02/16/2021
COLOPLAST A/S SENSURA MIO OSTOMY POUCH 02/10/2021
HOLLISTER INCORPORATED NEW IMAGE FLEXTEND CUT TO FIT BARRIER 02/09/2021
TORBOT GROUP, INC. SKIN TAX BARRIER WIPE 02/02/2021
HOLLISTER INCORPORATED PREMIER SOFT CONVEX CERAPLUS UROSTOMY PO 02/02/2021
HOLLISTER INCORPORATED NEW IMAGE DRAINABLE POUCH WITH FILTER AN 01/26/2021
HOLLISTER INCORPORATED PREMIER FLEXTEND DRAINABLE POUCH WITH TA 01/26/2021
HOLLISTER INCORPORATED MODERMA FLEX SOFT CONVEX CERAPLUS UROSTO 12/15/2020
HOLLISTER INCORPORATED POUCH, OSTOMY (POUCH, DRAINABLE, PREMIER 10/07/2020
HOLLISTER INCORPORATED PREMIER CERAPLUS CUT TO FIT BARRIER WITH 09/15/2020
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