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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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55 records meeting your search criteria returned- Product Code: OTN Product Problem: Material Erosion Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
COLOPLAST A/S ARIS (SLING ONLY) 10/18/2022
COLOPLAST A/S ARIS TRANSOBTURATOR KIT 10/14/2022
Unknown Manufacturer TRANSVAGINAL MESH 09/20/2022
COLOPLAST A/S ARIS TRANSOBTURATOR KIT 04/05/2022
COLOPLAST A/S ARIS TRANSOBTURATOR KIT 03/17/2022
ETHICON INC. GYNECARE TVT OBTURATOR 01/14/2022
ETHICON INC. GYNECARE TVT OBTURATOR 11/25/2021
JOHNSON & JOHNSON / GMED HEALTHCARE BVBA GYNECARE TVT ABBREVO TVTOML 09/21/2021
GYNECARE - ETHICON US LLC / ETHICON, INC TVTOML MESH ABBREVO TVT 12CM 09/14/2021
JOHNSON & JOHNSON / ETHICON, INC. GYNECARE TVT-O 09/13/2021
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