BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    MeDioStar

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

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506058875·Super Flexible Brain Spatulas, Ebonized, Mallea...

    POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MATRESPONDER TOURNIQUET

    FDA Adverse Event
    Malfunction ·PYNG MEDICAL·Product code GAX·November 18, 2020

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

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

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH·Product code NEW·July 17, 2013

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

    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, 13 X 145 MM, Silicone, Sterile, Item 431192.

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

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