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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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6 records meeting your search criteria returned- Product Code: HSX Product Problem: Noise, Audible Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL PRECOAT TIBIAL C 11/11/2019
ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL HIGH FLEX PRECOA 11/11/2019
MAKO SURGICAL CORP. UNKNOWN MAKO BASEPLATE 08/31/2018
MAKO SURGICAL CORP. UNKNOWN MAKO FEMORAL COMPONENT 08/31/2018
SMITH AND NEPHEW ORTHOPAEDICS AG VISIONAIRE 03/22/2018
SMITH AND NEPHEW ORTHOPAEDICS AG VISIONAIRE 03/22/2018
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