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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 5600 INTEGRATED SYSTEM 03/27/2024
ABBOTT LABORATORIES ALINITY I PROCESSING MODULE 02/28/2024
ABBOTT LABORATORIES ARCHITECT C4000 02/27/2024
ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE 02/27/2024
ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 3600 IMMUNODIAGNOSTIC SYSTEM 02/16/2024
ABBOTT LABORATORIES ARCHITECT C8000 02/15/2024
ABBOTT LABORATORIES ALINITY I PROCESSING MODULE 02/10/2024
SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 02/05/2024
ABBOTT LABORATORIES ARCHITECT I1000SR 01/30/2024
SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500 01/11/2024
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