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

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    BETA-2 MICROGLOBULIN EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    OnBrace Crown LR3 (5/pk)

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199013330·

    S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 30, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 8, 2013

    SCD EXPRESS SLEEVE K/L MEDIUM

    FDA Adverse Event
    Death ·COVIDIEN·Product code JOW·November 3, 2010

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 27, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 28, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 12, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·April 2, 2018

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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