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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
 

 
 
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20 records meeting your search criteria returned- Product Code: OQY Product Problem: Material Puncture/Hole Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
COOK INC BAKRI TAMPONADE BALLOON CATHETER 03/21/2024
COOK INC BAKRI TAMPONADE BALLOON CATHETER 03/19/2024
COOK INC BAKRI TAMPONADE BALLOON CATHETER 02/20/2024
COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID 02/05/2024
COOK INC BAKRI TAMPONADE BALLOON CATHETER 08/25/2022
COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID 05/23/2022
ALYDIA HEALTH JADA SYSTEM 03/02/2022
COOK INC BAKRI TAMPONADE BALLOON CATHETER 11/04/2020
COOK INC BAKRI TAMPONADE BALLOON CATHETER 10/20/2020
COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID 06/30/2020
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