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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
 

 
 
9 records meeting your search criteria returned- Product Code: OWB Product Problem: Material Integrity Problem Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM 12/07/2022
SIEMENS HEALTHCARE GMBH-AT ARTIS ZEE BIPLANE 04/01/2022
SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF 06/29/2021
SIEMENS HEALTHCARE GMBH- AT ARTIS ZEE CEILING 10/07/2020
SIEMENS HEALTHCARE GMBH- AT ARTIS ZEE FLOOR 09/30/2020
SIEMENS HEALTHCARE GMBH- AT ARTIS Q BIPLANE 09/25/2020
SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF 07/01/2020
SIEMENS HEALTHCARE GMBH - AT ARTIS ZEE CEILING 06/22/2020
SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF 06/18/2020
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