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

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    NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074032122·BONE SCREW 7041845 10 DEG ILC 8.5X45 TI

    Lombart Instrument, Inc. d/b/a Marco Ophthalmic

    FDA registration
    Lombart Instrument, Inc. d/b/a Marco Ophthalmic·2 products·🇺🇸 United States

    MALLINCKRODT, GOODKNIGHT 418S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MILLCOMP

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013

    VITALITY DS VR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025

    M-LNCS Y-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·August 12, 2017

    PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018