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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
ARTHREX, INC. IMPLANT SYSTEM, FIBERTAK BUTTON 05/13/2024
SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE) 05/13/2024
ARTHREX, INC. ACL TIGHTROPE 05/13/2024
ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, HIP 05/13/2024
SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/ 2 UB-BL &BLK 05/13/2024
SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL, CBRD BL 05/13/2024
ARTHREX, INC. FIBERTAK 05/13/2024
ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR 05/13/2024
SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 05/10/2024
ARTHREX, INC. FIBERTAK WITH SUTURETAPE 05/10/2024
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