BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Hooks

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114308·SINSKEY IOL HOOK ANG (BX/3)

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709043497·Safeset™ Mounting Bracket

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776207274·Switching Stick

    K133801

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2024

    BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KYPHX HV-R, MODEL C01A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 20, 2024

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 26, 2021

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 27, 2020

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    S-ROM*SLEEVE PRX ZTT, 14B-SML

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code KXA·November 6, 2014

    ASR UNI FEMORAL IMPL SIZE 39

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 4, 2011

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 16, 2013

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021