BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832014521·DRILL BIT

    OPTI-FREE EXPRESS LENS DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TWILITE, TWILITE WHITE

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

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018

    CROSSLINK ANCHOR PG GLENOID 44

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWS·April 2, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·March 7, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

    TSRH

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 25, 2011

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016