BEUDAMED
    11 results · 19ms · 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.

    DigniCap Scalp Cooling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Silicone PIP

    FDA UDI
    Stryker GmbH·00886385021362·Starter Awl

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776177577·BREISKY .

    FIT CHECKER ADVANCED

    FDA 510(k)
    FDA Class 2 ·Dental

    STARION UNIVERSAL POWER SUPPLY

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 7, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2020

    IN.PACT ADMIRAL

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·August 17, 2017

    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021