BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    Nihon Kohden Afib Detection Program QP-039P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637994·CoRoent Ant TLIF PEEK, 15x12x30mm 15°

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756669764·POST-OP SHOE

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055073·

    NexGen

    FDA UDI
    Zimmer, Inc.·00889024520905·

    MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A

    FDA 510(k)
    FDA Class 2 ·Radiology

    HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P

    FDA 510(k)
    FDA Class 2 ·Dental

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 21, 2014

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 7, 2013

    KIT, SOLERA STANDARD DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    ProScreen 8 Panel Dip Card, Item No. PSD-8P

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    E-Z-EM brand, Basic biopsy tray, catalog no. 4125.

    FDA Recall
    Terminated ·North Coast Medi-Tek Inc·Product code LRO·June 23, 2004

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024