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

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    Enteral Transition Adaptor

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SternVantage® Impression Mat'l Intraoral tips 50 pcs

    FDA UDI
    STERNGOLD DENTAL LLC·00841549115950·Allows for application of impression material d...

    K-Systems

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

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361036005·FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SA...

    TriVerse Femoral Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215097875·

    INTRAOSSEOUS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Single Use Ureteral Access Sheath

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    CERTAIN GOLD-TITE HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 7, 2024

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014

    10-LEAD ECG TRUNK CABLE, 12-PIN, 1.3M

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 11, 2011

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 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