BEUDAMED
    902 results · 9ms · Sources: EU EUDAMED, US FDA

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    The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·October 12, 2022

    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

    FDA Enforcement
    Class II ·Ongoing·Echonous Inc·July 17, 2024

    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    FDA Enforcement
    Class II ·Ongoing·REPLIGEN CORPORATION·January 21, 2026

    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·May 25, 2022

    Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health·December 14, 2022

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·July 9, 2025

    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·June 1, 2022

    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO

    FDA Enforcement
    Class II ·Ongoing·Scholly Fiberoptic Gmbh·August 16, 2023

    Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.

    FDA Enforcement
    Class II ·Ongoing·WANDERCRAFT SAS·May 14, 2025

    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 Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024

    ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·August 9, 2023

    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health·December 14, 2022

    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health·December 14, 2022

    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health·December 14, 2022

    MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781

    FDA Enforcement
    Class II ·Ongoing·Angiodynamics, Inc.·March 27, 2024

    Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341

    FDA Enforcement
    Class II ·Ongoing·Biomet, Inc.·February 1, 2023

    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade

    FDA Enforcement
    Class II ·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·July 10, 2024