BEUDAMED
    31 results · 13ms · Sources: EU EUDAMED, US FDA

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

    QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

    FDA Enforcement
    Class II ·Ongoing·Quidel Corporation·September 17, 2025

    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·July 23, 2025

    ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

    FDA Enforcement
    Class II ·Ongoing·B. Braun Medical, Inc.·October 26, 2022

    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

    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

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

    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

    True 3D Viewer, Model: EP-00003

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025

    CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·March 20, 2024

    Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·August 31, 2022

    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

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

    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

    FDA Enforcement
    Class II ·Ongoing·Zimmer Surgical Inc·February 21, 2024

    Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

    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

    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

    Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

    Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

    Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 24, 2024