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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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12 records meeting your search criteria returned- Product Code: MBI Product Problem: Manufacturing, Packaging or Shipping Problem Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
SMITH & NEPHEW, INC. BIOSURE PK 8 X 25MM 06/16/2022
SMITH & NEPHEW, INC. BIOSURE PK 7 X 25MM 05/20/2022
SMITH & NEPHEW, INC. TWINFIX TI 2.8 DURABRAID 01/06/2022
ARTHREX, INC. KNOTLESS HIP FIBERTAK 12/07/2021
ARTHREX INC. IMPLANT SYSTEM HAND/WRIST INTERNALBRACE 09/27/2021
SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL 04/05/2021
SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/2 UB-WHT & BL 04/05/2021
CETERIX ORTHOPAEDICS, INC NOVOCUT SUTURE MANAGER 03/14/2021
DEPUY MITEK LLC US EXPRESSEW III W/O HOOK 12/31/2019
CAYENNE MEDICAL SURELOCK 2.2MM ANCHOR FLEX 03/21/2019
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