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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT 03/22/2024
BECKMAN COULTER DXC 700 AU CLINICAL CHEMISTRY ANALYZER 03/22/2024
BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER 03/22/2024
SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 XPI SYSTEM 03/22/2024
ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM 03/21/2024
ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT 03/21/2024
ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE 03/21/2024
ABBOTT LABORATORIES ARCHITECT C16000 03/21/2024
SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 03/20/2024
ABBOTT LABORATORIES ARCHITECT C16000 03/20/2024
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