BEUDAMED
    13 results · 36ms · Sources: EU EUDAMED, US FDA

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    Arthrex Cannulated Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037318256·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506058868·Super Flexible Brain Spatulas, Ebonized, Mallea...

    VitriGuard

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

    Disposable Face Mask

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

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·August 16, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014

    ACTIVECARE +SFT HOMECARE

    FDA Adverse Event
    Other ·MEDICAL COMPRESSION SYSTEMS·Product code JOW·July 17, 2013

    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

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    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