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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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10 records meeting your search criteria returned- Product Code: HWE Patient Problem: Tissue Damage Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
DEPUY SYNTHES PRODUCTS LLC RADIOLUCENT-DRIVE 03/23/2020
DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT, LONG, FOR TRS 03/12/2020
ARTHREX, INC. FLIPCUTTER II, SHORT 10MM 11/07/2019
AESCULAP AG MICRO-LINE DRILL HDPC F/GB103R-GB108R 09/26/2019
AESCULAP AG MICRO FLEXIBLE CABLE 2.3M 09/26/2019
AESCULAP AG SPARE CUTTER F/GB304R/GB305R/GB308R 09/26/2019
ZIMMER BIOMET, INC. PRESSURE SENTINEL FLEXIBLE REAMER 6.0 MM 09/19/2018
ZIMMER BIOMET, INC. PRESSURE SENTINEL FLEXIBLE REAMER 7.0 MM 09/19/2018
STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW 11/21/2017
DEPUY SYNTHES POWER TOOLS COMPACT AIR DRIVE II 02/17/2016
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