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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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75 records meeting your search criteria returned- Product Code: NEU Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER 04/28/2017
DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BREAST BIOPSY SITE MARKER 04/06/2017
DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BIOPSY SITE MARKER 03/26/2017
DEVICOR MAMMOMARK 02/19/2017
DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BREAST BIOPSY MARKER 02/02/2017
FOCAL THERAPEUTICS, INC BIOZORB MARKER 01/13/2017
DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK REVOLVE 12/01/2016
CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER 11/22/2016
FOCAL THERAPEUTICS, INC BIOZORB MARKER 10/05/2016
DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK 09/21/2016
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