BEUDAMED
    130 results · 11ms · Sources: EU EUDAMED, US FDA

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    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code KQJ·July 21, 2025

    Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·August 31, 2021

    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code EQJ·July 5, 2024

    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

    FDA Recall
    Open, Classified ·Gyrus ACMI, Inc.·Product code EQJ·August 3, 2017

    LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·December 5, 2024

    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code KRO·November 10, 2025

    LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code JWH·April 25, 2023

    Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code FZX·November 30, 2023

    LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·January 22, 2024

    B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02

    FDA Recall
    Open, Classified ·B. Braun Medical, Inc.·Product code FMF·August 7, 2023

    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02

    FDA Recall
    Open, Classified ·B. Braun Medical, Inc.·Product code FMF·August 7, 2023

    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

    X3 TRIATHLON CS INSERT NO 3 10 MM

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

    Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025

    Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025

    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

    X3 TRIATHLON CS INSERT NO 6 11 MM

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

    X3 TRIATHLON CS INSERT NO 7 9 MM

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024

    Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·February 14, 2025

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024