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

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    COLORMATE TLC BILITEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756333054·Adult Anesthesia Circuit

    PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 16, 2026

    INFLOW TUBING FMS VUE 24PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·April 5, 2022

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·March 8, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 25, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·February 15, 2008

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022

    INFLOW TUBING FMS VUE 24PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·March 29, 2022

    INFLOW TUBING FMS VUE 24PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·March 30, 2022

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021

    INFLOW TUBING FMS VUE 24PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·November 29, 2022

    ATELLICA NEPH 630 SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

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

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