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

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    DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450672501·

    INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SPECTRAPULSE

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    AZUR VASCULAR PLUG 8

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·March 29, 2022

    PANORAMA TELEPACK

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 21, 2014

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·May 3, 2011

    BD SYRINGE 3ML HEPARIN

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·June 8, 2016

    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