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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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21 records meeting your search criteria returned- Product Code: JDR Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID 05/19/2021
SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID 05/19/2021
SMITH & NEPHEW, INC. DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID 05/17/2021
DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA 11/13/2019
DEPUY MITEK LLC US GII QA+ #2 ETH CP-2 *EA 08/21/2019
DEPUY MITEK LLC US GII QA+ #2 ETH CP-2 *EA 08/21/2019
DEPUY MITEK LLC US GII QA+ #2 ETH CP-2 *EA 08/21/2019
DEPUY MITEK LLC US SUPER QA+ O/C DS CP-2 *EA 07/03/2019
NOVASTEP ARCAD EXPRESS 06/26/2019
NOVASTEP ARCAD EXPRESS 06/26/2019
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