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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
 

 
 
8 records meeting your search criteria returned- Product Code: IZH Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D 09/09/2021
HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D 09/09/2021
HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D 09/09/2021
HOLOGIC, INC MULTICARE PLATINUM 01/15/2019
GE MEDICAL SYSTEMS SCS PERFORMA STEREO 10/09/2017
GE MEDICAL SYSTEMS SCS SENOGRAPHE 800T 09/15/2017
Unknown Manufacturer MAMMOGRAM 06/05/2017
Unknown Manufacturer SYSTEM, X-RAY, MAMMOGRAPHY 02/28/2017
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