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

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    EKOS MICRO-INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108345·BARRAQUER NEEDLE HOLDER CURVED WITH LOCK

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180500989·Slap Hammer Adapter, Large Battalion Backend

    NSI HEXED AND NON-HEXED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·March 29, 2013

    FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·September 5, 2014

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·June 19, 2008

    MENTOR SILTEX CONTOUR PROFILE HIGH

    FDA Adverse Event
    Injury ·Product code FWM·June 11, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018