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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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19 records meeting your search criteria returned- Product Code: CGA Product Problem: Overheating of Device Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER 06/29/2020
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER 08/14/2019
PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER 05/17/2019
NOVA BIOMEDICAL CORPORATION STATSTRIP GLUCOSE HOSPITAL METER SYSTEM 10/19/2016
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 10/10/2016
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 02/23/2016
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 09/08/2015
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 08/12/2015
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 07/17/2015
ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY 07/05/2015
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