BEUDAMED
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    Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)

    FDA Enforcement
    Class II ·Ongoing·Agfa Healthcare NV·October 16, 2024

    Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Plum Duo Precision IV Pump, 40002-0403

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Plum Duo Infusion Pump, 40002-0401

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Plum Solo Precision IV Pump, 40001-0401

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·June 17, 2026

    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 27, 2026

    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

    Portex Spinal Tray, Item No. A3729-24 A3595

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·January 21, 2026

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    Plum Duo Infusion System, List Number 40002-04-01

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 21, 2026

    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·January 28, 2026

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025

    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·November 5, 2025