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

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

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·November 26, 2025

    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·November 26, 2025

    BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X

    FDA Enforcement
    Class II ·Ongoing·Argon Medical Devices, Inc·October 2, 2024

    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515107 BD PhaSeal Protector (P55), REF: 515117 BD PhaSeal Connector Luer Lock (C35), REF: 515200 BD PhaSeal Connector Luer Lock (C45), REF: 515202 BD PhaSeal Y-site Connector (C80), REF: 515304 BD PhaSeal L Connector (C90), REF: 515305 BD PhaSeal Infusion Adapter (C100), REF: 515306 BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307 BD PhaSeal Cap for Injector (M50), REF: 515404 BD PhaSeal Connector Cap (M70), REF: 515406 BD PhaSeal Optima Injector (N35-O), REF: 515052 BD PhaSeal Optima Injector (N35-O Multi), REF: 515053 BD PhaSeal Injector Locking (N40-O), REF: 515056 BD PhaSeal Injector Locking (N40-O Multi), REF: 515057 BD PhaSeal Optima Protector (P13-O), REF: 515060 BD PhaSeal Optima Protector (P13-O Multi), REF: 515062 BD PhaSeal Optima Protector (P28-O), REF: 515063 BD PhaSeal Optima Protector (P20-O), REF: 515064 BD PhaSeal Optima Protector (P20-O Multi), REF: 515065 BD PhaSeal Optima Connector (C35-O), REF: 515070 BD PhaSeal Optima Infusion Adapter (C100-O), 515078 BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·September 3, 2025

    Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·March 6, 2024

    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

    FDA Enforcement
    Class II ·Ongoing·Moximed, Inc.·January 1, 2025

    Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·December 13, 2023

    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Neuromodulation Corporation·June 5, 2024

    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc·May 25, 2022

    Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 12, 2020

    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L

    FDA Enforcement
    Class II ·Ongoing·Medtronic Perfusion Systems·May 22, 2024

    Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·October 2, 2024

    ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive

    FDA Enforcement
    Class II ·Ongoing·ConvaTec, Inc·December 28, 2022

    META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·May 28, 2025

    Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023

    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·December 13, 2023