BEUDAMED
    16 results · 35ms · Sources: EU EUDAMED, US FDA

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    Electric Breast Pump (F5055)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AGXO

    FDA UDI
    Sbo Hearing A/S·05714464053322·AGXO F200 MINIRITE R C091

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017965·K-Wire, Single Ended, Trocar Point, Diameter Si...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215750·No-Profile Interbody, 2-Hole Faceplate 18mm

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123204571·MIX FCPS P-P 5-3/8

    SURGICAL MASK, Model Name:C015

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

    Digiscan FDX

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEN NDL 32G 4MM PRO 100 BOX AP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 6, 2020

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    PROXIMATE** RELOADABLE LINEAR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 22, 2013

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

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