BEUDAMED
    75 results · 16ms · Sources: EU EUDAMED, US FDA

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

    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·August 14, 2024

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    FDA Enforcement
    Class II ·Ongoing·MAX LUX CORP·December 8, 2021

    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 25, 2023

    EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

    FDA Enforcement
    Class II ·Ongoing·MHC Medical Products LLC·May 16, 2018

    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

    FDA Enforcement
    Class II ·Ongoing·MHC Medical Products LLC·May 16, 2018

    Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus.

    FDA Enforcement
    Class II ·Ongoing·NuVasive Specialized Orthopedics, Inc.·November 27, 2024

    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·April 15, 2026

    BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·October 29, 2025

    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 14, 2026

    STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

    FDA Enforcement
    Class II ·Ongoing·Diagnostica Stago, Inc.·May 17, 2023

    BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 11, 2024

    STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

    FDA Enforcement
    Class II ·Ongoing·Diagnostica Stago, Inc.·May 17, 2023

    OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0

    FDA Enforcement
    Class II ·Ongoing·Advanced Instruments, LLC·May 8, 2024

    AlternatiV+ Max Knotless Anchor

    FDA Enforcement
    Class II ·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026

    LUMINOS Lotus Max (VF11)

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·May 31, 2023

    UROSKOP Omnia Max. Model Number: 10762473

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 25, 2025

    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

    FDA Enforcement
    Class II ·Ongoing·Johnson & Johnson Vision Care, Inc.·July 30, 2025