BEUDAMED
    76 results · 12ms · Sources: EU EUDAMED, US FDA

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    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 1, 2023

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    Blood Type Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    VIDAS RUB IgG (RBG), REF 30226

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Pediatric care bed; Product Designation: KayserBett IDA;

    FDA Enforcement
    Class I ·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026

    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

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

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

    Endo-Model Replacement Plateau; Item Number: 15-8521/09;

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