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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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8 records meeting your search criteria returned- Product Code: MAX Product Problem: Off-Label Use Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM 07/16/2020
SPINEEX, INC. SAGITTAE 05/09/2019
SEASPINE INC. REGATTA LATERAL SYSTEM 04/11/2019
WENZEL SPINE, INC. VARILIFT-LX 05/04/2018
WENZEL SPINE, INC. VARILIFT-L 06/22/2016
WENZEL SPINE, INC. VARILIFT-LX 05/17/2016
MEDTRONIC SOFAMOR DANEK CAPSTONE SPINAL SYSTEM 10/10/2014
MEDTRONIC SOFAMOR DANEK CAPSTONE SPINAL SYSTEM 10/10/2014
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