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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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187 records meeting your search criteria returned- Product Code: HRX Product Problem: Mechanical Jam Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL 03/19/2024
MEDTRONIC MEXICO KYPHON KIS 03/06/2024
DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL 12/28/2023
MEDTRONIC MEXICO KYPHON EXPRESS¿ II INFLATABLE BONE TAMP 12/26/2023
MEDTRONIC MEXICO KYPHON EXPRESS¿ II INFLATABLE BONE TAMP 12/26/2023
MEDTRONIC MEXICO KYPHON EXPRESS¿ II INFLATABLE BONE TAMP 12/15/2023
DEPUY MITEK LLC US 4.0MM ROUND BURR PLUS 5PK 12/07/2023
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK 11/29/2023
DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL 11/28/2023
DEPUY MITEK LLC US BARREL BURR 4.0MM 5PK 11/02/2023
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