BEUDAMED
    804 results · 18ms · Sources: EU EUDAMED, US FDA

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    Genesis Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Max Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    AlternatiV+ Screw-In Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Fixone Hybrid Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025

    Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025

    XERF EFFECTOR 60. Electrosurgical unit.

    FDA Enforcement
    Class II ·Ongoing·Lutronic Corporation·October 22, 2025

    Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025

    Portable X-ray system

    FDA Enforcement
    Class II ·Ongoing·DIGIMED CO., LTD·July 30, 2025

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Enforcement
    Class II ·Ongoing·IDS LTD·January 15, 2025

    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella

    FDA Enforcement
    Class II ·Ongoing·CORENTEC CO., LTD·June 12, 2024

    LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

    FDA Enforcement
    Class II ·Ongoing·CORENTEC CO., LTD·June 12, 2024

    Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.

    FDA Enforcement
    Class II ·Terminated·KooJoo Trading Company·July 24, 2013

    Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Enforcement
    Class II ·Terminated·Won Industry Co.·December 13, 2017

    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

    FDA Enforcement
    Class II ·Terminated·CORENTEC CO., LTD·March 22, 2017

    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Enforcement
    Class II ·Terminated·Won Industry Co.·December 13, 2017

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    FDA Enforcement
    Class II ·Terminated·IntroMedic Co., Ltd.·May 9, 2018

    Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)

    FDA Enforcement
    Class II ·Terminated·ShinChang Medical Co., Ltd.·September 26, 2018

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    FDA Enforcement
    Class II ·Terminated·U&I CORP.·May 6, 2020

    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Enforcement
    Class II ·Terminated·Mediana Co., Ltd.·July 8, 2020