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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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28 records meeting your search criteria returned- Product Code: OTN Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ETHICON INC. GYNECARE TVT OBTURATOR W LASR 11/03/2023
COLOPLAST A/S SUPRIS RETROPUBIC KIT 09/20/2023
BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT BLUE SYSTEM 08/22/2023
UNKNOWN UNKNOWN TRANSVAGINAL MESH 08/12/2023
CALDERA MEDICAL DESARA BLUE OV 03/06/2023
BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM 09/06/2022
ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM 08/24/2022
BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM 06/16/2022
BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO 03/07/2022
COLOPLAST MANUFACTURING US, LLC COLOPLAST SLING 11/24/2021
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