BEUDAMED
    94 results · 14ms · Sources: EU EUDAMED, US FDA

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    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023

    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

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

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

    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

    VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·May 31, 2023

    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 2, 2025

    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

    FDA Enforcement
    Class II ·Ongoing·Philips North America·February 21, 2024

    Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

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

    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 11, 2023

    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 11, 2023

    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·January 11, 2023

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 18, 2023

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    FDA Enforcement
    Class III ·Ongoing·Ortho Clinical Diagnostics Inc·November 25, 2020

    Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023

    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023

    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·July 5, 2023

    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023

    Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023

    Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023

    Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 2, 2023