BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

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    PINS AND WIRES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810021251·Syngauze 50 Non-Woven N/S

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002125·artVeneer life lower posteriors, M, C4

    Tissue Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112847·BARRON ARTIFICIAL ANTERIOR CHAMBER

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167900021250·

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900021250·

    JET PORT PLUS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FEATHER-FLEX ADULT ANESTHESIA CIRCUIT

    FDA Adverse Event
    Malfunction ·BOMIMED INC.·Product code BSJ·August 28, 2014

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 30, 2012

    SURGITEK TEARDROP GEL-FILLED MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·MEDICAL ENGINEERING CORP.·Product code FTR·May 19, 1994

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 9, 2012

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 4, 2013

    2520274-2013-10216

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code MNI·February 11, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MTA·February 2, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 20, 2008

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·June 24, 2025

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 26, 2014

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012