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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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11 records meeting your search criteria returned- Product Code: FMK Product Problem: Improper or Incorrect Procedure or Method Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
ASCENSIA DIABETES CARE US INC. MICROLET 03/15/2024
ASCENSIA DIABETES CARE US INC. MICROLET 08/01/2022
Unknown Manufacturer FINGERSTICK DEVICE 06/13/2019
ASCENSIA DIABETES CARE US INC MICROLET 04/20/2018
ASCENSIA DIABETES CARE US INC. GLUCOLET2 02/20/2017
ASCENSIA DIABETES CARE US INC. MICROLET2 12/16/2016
ASCENSIA DIABETES CARE US INC. MICROLET2 08/02/2016
BAYER HEALTHCARE LLC MINILET 05/14/2015
BAYER HEALTHCARE LLC MICROLET2 02/18/2015
BAYER HEALTHCARE LLC MICROLET 01/22/2014
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