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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
7 records meeting your search criteria returned- Product Code: OTO Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
COLOPLAST A/S RESTORELLE Y SHAPED 24X4CM 12/06/2019
COLOPLAST A/S RESTORELLE Y 11/13/2019
COLOPLAST A/S RESTORELLE Y CONTOUR 09/23/2019
BOSTON SCIENTIFIC CORPORATION UPSYLON 09/10/2019
COLOPLAST CORP RESTORELLE Y CONTOUR 24X3CM 07/16/2019
COLOPLAST A/S RESTORELLE Y SHAPED 24X4CM 04/02/2019
COLOPLAST CORP RESTORELLE Y SHAPED 24X4CM 03/19/2019
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