BEUDAMED
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    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

    Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

    FDA Enforcement
    Class II ·Ongoing·Centinel Spine, Inc.·February 25, 2026

    COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·April 15, 2026

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

    nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

    FDA Enforcement
    Class II ·Ongoing·XTANT Medical Holdings, Inc·April 29, 2026

    Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·February 25, 2026

    Endo-Model Replacement Plateau; Item Number: 15-0027/15;

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026

    EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·March 18, 2026

    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026

    ALLURA Xper FD10F; System Code: 722002;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

    FDA Enforcement
    Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

    Artelon FlexBand Dynamic Matrix Ref: 31057

    FDA Enforcement
    Class II ·Ongoing·International Life Sciences·March 18, 2026

    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

    FDA Enforcement
    Class II ·Ongoing·Mentor Texas, LP.·April 8, 2026

    Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·April 22, 2026

    Burlington Medical, Wrap Aprons.

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

    FDA Enforcement
    Class II ·Ongoing·Mentor Texas, LP.·April 8, 2026

    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    CLARITY II Laser System; Model No. 1110200210.

    FDA Enforcement
    Class II ·Ongoing·Lutronic Corporation·March 18, 2026

    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·March 18, 2026