BEUDAMED
    34 results · 31ms · 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.
    Filters Regulation: Us FDA ×

    BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814756·GENUMEDI EXTRA WIDE SAND SIZE VII

    Bur PM2-70 80K Diam C Ø6.0

    FDA UDI
    Bien-Air Surgery SA·17630055513899·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005827·Arena-L, 38x28, Lordotic 12 degrees, 17H

    TruLink

    FDA UDI
    OSI OPTOELECTRONICS, INC.·00859998006446·SpO2 Y Multi-Site Sensor Reusable -Universal

    MX8000 V5.0 CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMEGA II MODULAR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYPODERMIC NEEDLE-PRO EDGE SAFET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC. / ICU MEDICAL, INC.·Product code FMI·November 7, 2025

    Widex

    FDA UDI
    Widex A/S·05706069727647·Widex EVOKE E-FA (Summer gold S-110 ) Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069727241·Widex EVOKE E-FM (Summer gold S-110 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069729641·Widex EVOKE E-FP (Summer gold S-110 ) Telecoil,...

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 24, 2025

    MIGHTYSAT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·December 14, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    D-TRONPLUS

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 6, 2008

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011

    Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·February 7, 2018

    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013

    Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.

    FDA Enforcement
    Class I ·Terminated·Symbios Medical Products, LLC·June 12, 2013