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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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4 records meeting your search criteria returned- Product Code: OWB Product Problem: Use of Incorrect Control/Treatment Settings Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
GE MEDICAL SYSTEMS SCS OPTIMA IGS 320 07/31/2023
GE MEDICAL SYSTEMS SCS INNOVA 3100 01/30/2023
SIEMENS HEALTHCARE GMBH LUMINOS AGILE MAX 08/22/2022
SIEMENS HEALTHCARE GMBH - AT ARTIS ZEE MULTIPURPOSE 06/18/2020
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