BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    EL-ANA PROFILES-2K1

    FDA 510(k)
    FDA Class 2 ·Immunology

    GC Capsule Applier IV

    FDA UDI
    Gc America Inc.·D0470025591·GC Capsule Applier IV

    CALCIUM SULFATE PELLETS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970072·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970102·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970089·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970119·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970096·

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013

    POLYURETHANE CONTRAST INJECTION LINE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·January 28, 2011

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·February 26, 2008

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024