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

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    Natural Cycles

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

    BD BBL™ Sensi-Disc™ Chloramphenicol 30 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902312742·BD BBL™ Sensi-Disc™ Chloramphenicol 30 µg

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111163807·SKLARLITE SKLRCT MAYO STR 6.75

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180160934·PRISM CERVICAL CURETTE 10" ANGLED 5-0, LIGHT GREY

    MODEL 5071 MYOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Ultrasonic Osteotomy Surgical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·March 8, 2026

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code PFO·January 15, 2024

    COCHLEAR OSIA OSI300 IMPLANT

    FDA Adverse Event
    Injury ·COCHLEAR LIMITED·Product code PFO·January 15, 2024

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 25, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 17, 2013

    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    BD PHOENIX PMIC/ID 69

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·February 9, 2021

    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733and 231274

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014