BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638809·CoRoent Ant TLIF PEEK, 8x10x32mm 12°

    Maestro™ Total Wrist

    FDA UDI
    Biomet Orthopedics, LLC·00887868239663·

    MAESTRO TOTAL WRIST

    FDA UDI
    Biomet Orthopedics, LLC·00880304479357·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197080675·NEIVERT Needle Holder 13 cm,...

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

    FDA 510(k)
    FDA Class 2 ·Immunology

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·March 27, 2019

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014