BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044575·Rongeur 4

    Harvard Cement normal setting, Clinic powder, Shade 15

    FDA UDI
    Harvard Dental International GmbH·EHAR70022151·Zinc phosphate cement

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964017603·Endo Carry-On Procedure Kit

    Astra

    FDA UDI
    Preat Corporation·00842092167311·Astra®-compatible Lilac 4.5/5.0mm Non-Engaging ...

    Disposable Sensor

    FDA UDI
    Honeywell Healthcare Solutions GmbH·04036616010054·Disposable Sensor DA-2211-1 MySign® FDA

    CUSTOMED

    FDA UDI
    CUSTOMED INC·M20890022151·PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR ...

    L1-M-002215

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Ze Fang Technology Co., Ltd.·1 device

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967188744·Battalion, LLIF Trial, 0°, 22 mm Wide, 15 mm X ...

    SWIVEL ELBOW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DBEST HCG 2 IU/ML TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·March 13, 2013

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·February 18, 2011

    ULTIMA FEM STEM, M SERIES, SZ2M

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWL·February 21, 2008

    INTEGRAL/XLAT POR PROFILE 13MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 28, 2014

    M2A-MAGNUM 42-50M TPR INSRT +3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 28, 2014

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 28, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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

    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