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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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9 records meeting your search criteria returned- Product Code: FKX Product Problem: Tear, Rip or Hole in Device Packaging Report Date From: 01/1/2014
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ManufacturerBrand NameDate Report Received
BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETT 09/24/2018
BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET 09/18/2018
BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET 07/20/2018
BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETT 02/27/2017
BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETT 02/02/2017
BAXTER HEALTHCARE - MOUNTAIN HOME NI 11/03/2016
BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETT 09/26/2016
BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETT 08/31/2015
FRESENIUS MEDICAL CARE NORTH AMERICA, RE LIBERTY CYCLER SET, SINGLE CONN/ECT DL 05/28/2015
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