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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
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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 E 411 ANALYZER (RACK SYSTEM) 03/15/2024
ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE 03/15/2024
ABBOTT LABORATORIES ALINITY C PROCESSING MODULE 03/15/2024
ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK SYSTEM) 03/14/2024
ABBOTT LABORATORIES ALINITY C PROCESSING MODULE 03/14/2024
SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500 03/14/2024
ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE 03/14/2024
ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE 03/14/2024
ABBOTT LABORATORIES ARCHITECT C16000 03/14/2024
BECKMAN COULTER DXC 700 AU CLINICAL CHEMISTRY ANALYZER 03/13/2024
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