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

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    GLUCODR AUTO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Harvard PremiumFlow OptiTips A2

    FDA UDI
    Harvard Dental International GmbH·EHAR70836281·Flowable light cure nano-hybrid composite for r...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A08362880·8mm H x 36mm W x 28mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A083628150·8mm H x 36mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A083628120·8mm H x 36mm W x 28mm L x 12 degrees ALIF

    MAGNETOM RHAPSODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·November 13, 2023

    POWERED PATIENT ROTATION BED

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code IKZ·April 29, 2013

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·May 10, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2008

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL, INC·Product code CBK·December 13, 2023

    AMISTEM H CEMENTLESS STEM SIZE 7 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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