BEUDAMED
    9 results · 23ms · 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 ×

    Tesera-k ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Laser Therapy Device

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

    GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX KNEE

    FDA Adverse Event
    Injury ·OMNLIFE SCIENCE, INC.·Product code JWH·October 24, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·August 8, 2011

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023