BEUDAMED
    1,845 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 24, 2026

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·June 10, 2026

    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

    FDA Enforcement
    Class I ·Ongoing·Omnicell, Inc.·May 20, 2026

    Atlan A350. Model Number: 8211500. anesthesia workstation

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·June 10, 2026

    Automated Impella Controller (AIC); Product Code: 0042-0000-US;

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    Impella RP Flex with SmartAssist. Product Code: 1000323.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·April 8, 2026

    Impella RP with SmartAssist. Product Code: 0046-0035.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    Impella RP. Product Code: 0046-0011.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 31, 2025

    Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 31, 2025

    Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

    FDA Enforcement
    Class I ·Ongoing·Dexcom, Inc.·November 5, 2025

    ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·December 17, 2025

    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

    FDA Enforcement
    Class I ·Ongoing·Dexcom, Inc.·September 10, 2025