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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
 

 
 
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138 records meeting your search criteria returned- Product Code: HRX Product Problem: Metal Shedding Debris Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK 05/18/2018
MEDOS INTERNATIONAL SàRL MINI FULL RADIUS BLADE PLUS 05/14/2018
MEDOS INTERNATIONAL SàRL MINI FULL RADIUS BLADE PLUS 05/14/2018
MEDOS INTERNATIONAL SàRL MINI FULL RADIUS BLADE PLUS 05/14/2018
DEPUY MITEK ULTRA AGGRESSIVE PLUS 5.0 5PK 05/04/2018
STRYKER INSTRUMENTS-KALAMAZOO PIN COLLET (2.0-3.2MM) 04/26/2018
STRYKER INSTRUMENTS-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE 04/26/2018
DEPUY MITEK LLC US 4 MM AGGRESSIVE BLADE PLUS 04/26/2018
DEPUY MITEK LLC US 4 MM AGGRESSIVE BLADE PLUS 04/26/2018
DEPUY MITEK LLC US 4 MM AGRESSIVE BLADE PLUS 04/26/2018
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