BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    DOMED AND FINNED ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517174062·VuePoint Screw, 3.5x28mm Polyaxial Tulip

    OnBrace Crown UL5 (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199013280·

    SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 17, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 11, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 21, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·November 13, 2010

    PERFIX PLUG

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 17, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 11, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 10, 2023

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 23, 2019

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021