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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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27 records meeting your search criteria returned- Product Code: OWB Patient Problem: Unintended Radiation Exposure Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM 06/19/2023
SIEMENS HEALTHCARE GMBH-AT CIOS FUSION 04/19/2023
SIEMENS HEALTHCARE GMBH-AT ARTIS Q CEILING 04/05/2023
GE MEDICAL SYSTEMS SCS INNOVA IGS 520 04/26/2022
GE MEDICAL SYSTEMS SCS INNOVA 3100-IQ 12/17/2021
GE MEDICAL SYSTEMS SCS INNOVA 3100 12/17/2021
GE MEDICAL SYSTEMS SCS INNOVA IGS 630 12/13/2021
Unknown Manufacturer INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM 10/26/2021
GE MEDICAL SYSTEMS SCS INNOVA IGS 520 10/05/2021
SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM 09/02/2021
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