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

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    “BioGend” Interbody Fusion System 001 Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364735·IdentiTi ALIF SA, Detachable Driver Sleeve

    Goody Gloves, Wincare, TBG Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Plus Surgical Gowns (EO Sterilized), PMGB-XXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD ULTRASAFE¿ PLUS X100L

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·September 19, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    Z-FLO

    FDA Adverse Event
    Malfunction ·SUNDANCE ENTERPRISES·Product code FMP·September 1, 2011

    CROCODILE GRASPER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 18, 2013

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025