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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
 

 
 
6 records meeting your search criteria returned- Product Code: LOE Product Problem: Adverse Event Without Identified Device or Use Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ZIMMER BIOMET SPINE INC. EBI SPF-XL IIB BONE GROWTH STIMULATOR 05/03/2019
EBI, LLC. SPF-PLUS 60/M 05/01/2019
EBI, LLC. OSTEOGEN-20/M SURGICALLY IMPLANTED BONE 03/26/2019
EBI, LLC. OSTEOGEN-20/M SURGICALLY IMPLANTED BONE 03/26/2019
EBI, LLC. SPF-PLUS 60/M 03/04/2019
EBI, LLC. EBI OSTEOGEN-20/M BONE GROWTH STIMULATOR 11/28/2018
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