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

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    MotoBand¿ CP Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756669771·POST-OP SHOE

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055080·

    SYNOVIS COLLAGEN MATRIX (TBD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 7, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 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

    Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue

    FDA Recall
    Terminated ·Medline Industries Inc·Product code INI·July 20, 2006

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020