BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SALINE IV FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THE QUIET SLEEPER

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    BD ANGIOCATH¿ PLUS IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 9, 2018

    MORPHEUS CT PICC

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS INC.·Product code LJS·April 11, 2013

    KOTEX SECURITY TAMPONS

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION·Product code HEB·April 27, 2011

    IMPELLA RECOVER LP 2.5 CARDIAC SUPPORT SYSTEM

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code KFM·July 25, 2008

    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