BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

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

    AVANTE CURELIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    SMALL UNIVERSAL CHUCK WITH T-HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·April 17, 2013

    HIGH SPEED VITRECTOMY CUTTER

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code MLZ·June 19, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 19, 2011

    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