BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Serafin®

    FDA 510(k)
    FDA Class 2 ·Dental

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025057·G85 Mini Incubator

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM

    LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Apache Ultrasound System (Model C62)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A 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: No

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

    LIGASURE V 5 MM SEALER DIVIDER

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·November 7, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    G85 MINI INCUBATOR WITH

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code PUB·May 24, 2023

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·October 4, 2022

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A 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: No

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