BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PRECISION? MONTAGE? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 25, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025

    CLEANAIR/ CLEANWATER UNIT, MODEL 1600

    FDA 510(k)
    FDA Class 1 ·Dental

    VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 23, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 9, 2014

    IDENTITY ADX DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    NUVASIVE HELIX ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024