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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
ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 350 CHEMISTRY SYSTEM 03/04/2024
ROCHE DIAGNOSTICS COBAS PRO ISE ANALYTICAL UNIT 03/04/2024
SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM 03/01/2024
ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS ANALYZER 03/01/2024
ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE 03/01/2024
ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE 02/29/2024
ABBOTT LABORATORIES ARCHITECT C16000 02/29/2024
ABBOTT LABORATORIES ALINITY I PROCESSING MODULE 02/29/2024
BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER 02/28/2024
ABBOTT LABORATORIES ARCHITECT C4000 02/28/2024
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