BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    AKCESS-CATH KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ORION YAG LASER SYSTEM OPHTHALMOLOGY

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

    TKO TELESCOPING LITHOTOMY STIRRUP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2009

    SERVO-S BASE UNIT

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 25, 2023

    UNKNOWN MESH PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code FTL·July 15, 2015

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·January 15, 2013

    PIN REV DOME DRILL 25MM

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.1818910·Product code LXH·July 4, 2014

    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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026