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

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    Exceed™ Biplanar Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Sensi-Disc™ Clindamycin 2 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902312759·BD BBL™ Sensi-Disc™ Clindamycin 2 µg

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182208·

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180160941·Prism Cervical Curette, 10" Angled 4-0, Purple.

    MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AirMax Procedure Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 7, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 14, 2020

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 25, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 6, 2014

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·July 17, 2013

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·June 16, 2021

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·January 9, 2026

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025