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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FFR Link, FFR Signal Processing Module

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    LINK Instruments - Chisel, bone curette, raspatory, rongeur

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575303854·Orthopaedic prosthesis instrument, reusable - G...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971956·

    LINK TO ACUITY CLINICIAN NOTIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONALIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYRINGE 5ML SALINE FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·July 7, 2021

    SYRINGE 5ML SALINE FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 27, 2021

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Other ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 5, 2011

    SPECTRA OPTIA

    FDA Adverse Event
    TERUMO BCT·Product code LKN·June 14, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    405 LS WASHER

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES INC.·Product code JQW·December 21, 2023

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016