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

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    BODY COMPOSITION ANALYZER, MODEL: IOI 353

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450263143·

    COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ELRAN 01 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SOL-MILLENNIUM

    FDA Adverse Event
    Malfunction ·SOL-MILLENNIUM MEDICAL INC·Product code FMF·May 16, 2025

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 13, 2020

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 13, 2020

    CATHETER, ELECTRODE RECORDING

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·May 3, 2013

    X SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 2, 2011

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    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