BEUDAMED
    18 results · 22ms · 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 ×

    Huxley SANSA Home Sleep Apnea Test (1000-00)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631053·CoRoent Ant TLIF Ti, 14x10x28mm 15°

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00613994908407·SHUNT 24028-5 DELTA ASY REG SNAP PER 1.5

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169483439·SHUNT 24028-5 DELTA ASY REG SNAP PER 1.5

    VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    B TRAVELSAVVY SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RESERVOIR

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FRN·June 26, 2018

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·May 12, 2010

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 22, 2018

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    ACCU-CHEK RAPID D INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEM·Product code FPA·June 2, 2008

    MINIVOLUME EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    HIWIRE NITINOL HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK, INC.·Product code OCY·July 18, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013