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

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    FIREBIRD SI Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·June 22, 2016

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116023301·400 Micron SU Thulio Performance 4.5m Fiber

    Classic by RISKONTROL

    FDA UDI
    ACTEON MANUFACTURING·03760243000492·Disposable single use tips for air/water syringe

    NA

    FDA UDI
    Synthes GmbH·10886982142320·2.4MM CORTEX SCREW SELF-TAPPING 34MM

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 23, 2020

    COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GE OEC 2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008

    SYMPHONY

    FDA Adverse Event
    Injury ·SORIN CRM·Product code NVZ·June 28, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    EVIS EXERA III COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDF·June 28, 2022

    EVIS EXERA III COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·March 30, 2023

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·September 19, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·September 19, 2018

    VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·May 14, 2024

    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