BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    KOLPLUX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 12, 2026

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    CANES

    FDA Adverse Event
    UNKNOWN·Product code IPS·September 23, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 1, 2011

    ATTUNE PS FEM RT SZ 3 NAR CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·October 18, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 6, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·February 9, 2023

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024