BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    AUTOBAHN(R) EVO Femoral Nails

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-Systems

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

    DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

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

    HU-FRIEDY DENTAL CARTRIDGE SYRINGE

    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

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AG HEALTHCARE CORP·Product code LLZ·July 8, 2013

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024