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

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    SMITH & NEPHEW INSTRUMENT TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 16, 2025

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY·Product code FMF·September 8, 2025

    LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OPENSAIL CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·GUIDANT VASCULAR INTERVENTION·Product code LOX·May 9, 2001

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·June 13, 2008

    2520274-2013-02365

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·May 3, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 16, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015