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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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61 records meeting your search criteria returned- Product Code: JJE Product Problem: Unable to Obtain Readings Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT 02/08/2023
ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT 12/05/2022
ABBOTT LABORATORIES ARCHITECT C4000 12/01/2022
ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE 10/21/2022
ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE 10/04/2022
ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT 05/09/2022
SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® 04/15/2022
ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT 03/21/2022
ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT 12/16/2021
BIOMERIEUX ITALIA S.P.A. VIDAS® ANALYZER 10/21/2021
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