BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    BRAINLAB MASK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Direct Inject

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327123371·DirectInject On-Demand HA Cement

    SPLASHMASTER PRESCRIPTION EYEWEAR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION

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

    EXTERNAL PADDLES

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

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·December 28, 2010

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·July 21, 2014

    ABC HANDPIECE LAPAROSCOPIC

    FDA Adverse Event
    Malfunction ·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020