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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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52 records meeting your search criteria returned- Product Code: ELW Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
KERR KERR 05/18/2018
GC AMERICA INC. EXA'LENCE REGULAR HEAVY 48 ML 02/27/2018
KULZER,LLC FLEXITIME MONOPHASE 10/10/2017
3M DEUTSCHLAND GMBH 3M ESPE IMPRINT 4 PRELIMINARY PENTA SQ 06/13/2017
HERAEUS KULZER SRL FLEXITIME 06/12/2017
HERAEUS KULZER SRL PROVO NOVIL P SOFT FAST 05/02/2017
HERAEUS KULZER SRL PROVIL NOVO L 05/02/2017
HERAEUS KULZER, SRL FLEXITIME XTREME 2 HEAVY TRAY 09/22/2016
HERAEUS KULZER, SRL FLEXITIME XTREME 2 CORRECT FLOW 09/22/2016
3M DEUTSCHLAND GMBH 3M ESPE IMPREGUM PENTA 07/08/2015
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