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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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18 records meeting your search criteria returned- Product Code: OBR Product Problem: Patient-Device Incompatibility Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
REMI NIGHT GUARD 10/04/2022
DENTEK ORAL CARE, INC. DENTEK ULTIMATE DENTAL GUARD FOR NIGHTTI 10/21/2021
RANIR LLC PLACKERS MTH GD GNM 10CT 10/12/2021
RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 06/18/2020
RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 06/09/2020
RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 05/04/2020
RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 2CT CD 03/20/2020
PRESTIGE BRANDS INC. DENTEK MAXIUMUM PROTECTION DENTAL GUARD 01/10/2019
RANIR LLC KROGER MTH GD RST ASRD W/TRAY 2CT 11/02/2018
RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 2CT 08/02/2018
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