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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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8 records meeting your search criteria returned- Product Code: GKP Product Problem: Use of Device Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
INSTRUMENTATION LABORATORY CO. ACL TOP 350 CTS 09/06/2022
SYSMEX RA CO., LTD. MAIN PLANT SYSMEX CA-660 07/06/2021
INSTRUMENTATION LABORATORY CO. ACL TOP 550 CTS 07/21/2020
INSTRUMENTATION LABORATORY COMPANY ACL TOP 300 CTS 06/11/2020
SYSMEX RA CO. LTD. CA-620 12/09/2019
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS BCS XP SYSTEM 08/21/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS BCS XP SYSTEM 08/21/2018
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS BCS XP SYSTEM 07/20/2018
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