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

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    GELSCAN, MODEL 1206

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bur PM2-70 50K Diam C Ø3.5

    FDA UDI
    Bien-Air Surgery SA·07630055502803·

    SMITH WIRE CUTTING SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896058958·SMITH WIRE CUTTING SCISSORS STRAIGHT SERRATED B...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001946·13mm Y Rigid Plate

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869654050·MOSS VRS Locking Cap Final Tightener HP, 1/4" c...

    PEN NEEDLE BD ULTRAFINE 32GX4MM /10EA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMI·March 26, 2021

    SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 4, 2020

    PEN NEEDLE 32X4 LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 26, 2021

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

    M2A TAPER 37/28MM LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 18, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·April 30, 2025

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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