BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Initial LiSi Block

    FDA 510(k)
    FDA Class 2 ·Dental

    Guide For BC BL RC System

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600304548·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197119·Revision Knee Spiral Reamer- Hudson Short Flute...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

    XELIS 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONYX II FINGER PULSE OXIMETER, MODEL 9550

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLSATOREN GMBH·Product code MSF·September 4, 2008

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·October 10, 2017

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019