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

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

    Allergy test Small

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    Adrenal Test

    FDA Enforcement
    Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    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

    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511

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

    ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

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