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

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    Passeo-35 Xeo Peripheral Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bernafon

    FDA UDI
    Bernafon AG·05714464008964·BERNAFON ALPHA 9 MNR T R MSIL/MAC

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator

    DYNACORD

    FDA UDI
    Medos International Sàrl·20886705029997·DYNACORD Suture Blue Braided Composite Suture O...

    ARKEO, Wedge Fixation System

    FDA UDI
    Auxano Medical LLC·00850055649880·ARKEO Cotton Wedge, 20x14x6.5

    SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 4, 2008

    COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0 CE-IVD

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS·Product code MKT·August 24, 2011

    SPACE PUMP IV SET

    FDA Adverse Event
    Malfunction ·B. BRAUN DOMINICAN REPUBLIC·Product code FPA·July 5, 2013

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024