BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    DIOPTRON III AUTOREFRACTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Symmetry Spetzler

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482032121·Symmetry® Forceps, Spetzler Platform, 30° Angle...

    PROTEX CT CERVICOTHORACIC SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECSYS INSULIN CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code GEY·February 11, 2014

    RESTORE

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code LGW·October 23, 2012

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 26, 2015

    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

    FDA Recall
    Terminated ·Catheter Connections, Inc.·Product code LKB·August 5, 2014

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024