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

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    Volumat Polyethylene I.V. Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004079·Luna Opal MB Mini .022 LL5 (-17°T +2°A)

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123206032·Halsey Needle Holder

    AROMACRYL

    FDA 510(k)
    FDA Class 2 ·Dental

    Sphincterotome

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

    Widex

    FDA UDI
    Widex A/S·05706069810011·Widex EVOKE E-FS (Titanium grey ) 220, Telecoil...

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·September 15, 2025

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·November 3, 2014

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·March 27, 2025

    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical Company·December 13, 2023

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020