BEUDAMED
    2 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair

    FDA Enforcement
    Class II ·Terminated·Valeris Medical, LLC·July 25, 2018

    Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.

    FDA Enforcement
    Class II ·Terminated·Valeris Medical, LLC·October 24, 2018