BEUDAMED
    15 results · 31ms · Sources: EU EUDAMED, US FDA

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    PC-60, NON-INVASIVEPULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOLOK SCREW, BIOSTEON SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

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

    BD FACSPRESTO REAGENT CARTRIDGE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKL·April 7, 2021

    OXF TWIN-PEG CMNTD FEM MD PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·September 28, 2022

    OXF UNI TIB TRAY SZ B LM PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·September 28, 2022

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 17, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·April 19, 2011

    HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 19, 2008

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 18, 2023

    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