BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    HydroMARK Breast Biopsy Site Markers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133074·LATERAL,TRIAL,6 DEG,22X8

    BRAIN COIL, MODEL 9800GE-64

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUEZONE PEAK FLOW METER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2024

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 23, 2014

    CONCERTO CRT-D DR AT

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025