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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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8 records meeting your search criteria returned- Product Code: OTN Product Problem: Hole In Material Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ETHICON INC. GYNECARE TVT OBTURATOR 01/04/2018
ETHICON INC. GYNECARE TVT OBTURATOR 12/15/2017
ETHICON INC. GYNECARE TVT OBTURATOR 12/15/2017
ETHICON INC. GYNECARE TVT OBTURATOR 12/15/2017
ETHICON SARL GYNECARE TVT OBTURATOR SYSTEM 08/11/2017
ETHICON SARL GYNECARE TVT EXACT CONTINENCE SYSTEM 11/23/2016
SOFRADIM PRODUCTION PARIETEX PCOX THR 37X28CM X1 08/04/2014
SOFRADIM PRODUCTION PARIETEX PCOX THR 20X15CM X1 05/07/2014
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