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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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188 records meeting your search criteria returned- Product Code: OTN Patient Problem: Burning Sensation Report Date From: 01/1/2009

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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO 10/31/2019
ETHICON INC. GYNECARE TVT OBTURATOR W LASR 10/31/2019
ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUC 10/30/2019
C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPO 10/28/2019
BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM 10/08/2019
COLOPLAST A/S ARIS TRANS-OBTURATOR KIT 09/26/2019
C.R. BARD, INC. (COVINGTON) -1018233 ALIGN URETHRAL SUPPORT SYSTEM 09/18/2019
SOFRADIM PRODUCTION SAS MESH SOFRADIM - URETEX 08/15/2019
ETHICON INC. GYNECARE TVT OBTURATOR W LASR 04/10/2019
ETHICON INC. GYNECARE TVT DEVICE 12/14/2018
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