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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
 

 
 
10 records meeting your search criteria returned- Product Code: DRO Product Problem: Peeled/Delaminated Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
CARDINAL HEALTH MEDITRACE RTS FOR MEDTRONIC 03/28/2023
CARDINAL HEALTH CADENCE HEARTSTREAM ADULT RTS 12/14/2021
CARDINAL HEALTH 3010188-020 QC RTS 1/P 10/B 50 08/31/2021
CARDINAL HEALTH 3010188-020 QC RTS 1/P 10/B 50 08/31/2021
COVIDIEN 3010188-020 QC RTS 1/P 10/B 50 06/18/2021
COVIDIEN 3010188-020 QC RTS 1/P 10/B 50 06/01/2021
COVIDIEN CADENCE HEARTSTREAM ADULT RTS 02/18/2021
COVIDIEN 3010188-020 QC RTS 1/P 10/B 50 07/14/2020
COVIDIEN CADENCE ZOLL PRECONNECT 06/17/2020
COVIDIEN MEDI-TRACE CADENCE 08/08/2017
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