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

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    Altapore MIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113479·MINIATURE BLADE #64 (BX/5)

    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517074017·

    DXTEND METAGLENE

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS 3003895575·Product code HSD·November 9, 2017

    LG Pra. L Derma LD Scalp Care

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DISPOSABLE H-PE MICROKERATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    UNKNOWN DEPUY SELF CENTERING BI POLAR HIP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·October 16, 2008

    TW POWER SUPPLY, US

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code HQO·August 4, 2011

    SYNCHROMED II

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

    UNK - SCREWS: VIPER 2

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MNH·July 8, 2022

    MEDTRONIC LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·April 28, 2023

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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