BEUDAMED
    78 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·January 22, 2025

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·December 8, 2021

    Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020

    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.

    FDA Enforcement
    Class II ·Ongoing·Macherey Nagel Gmbh & Co. Kg·May 22, 2024

    Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 15, 2024

    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·March 15, 2023

    8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024

    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026

    Endo-Model Replacement Plateau; Item Number: 15-2836/11;

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

    Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 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