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

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    PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

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

    INFLUENZA A/B RAPID TEST, CAT NO 2158 663

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

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

    COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JDI·December 15, 2016

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 17, 2017

    COBALT CHROME FEMORAL HEAD

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·October 29, 2014

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·April 25, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code KMW·July 7, 2022

    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

    FDA Recall
    Open, Classified ·Braemar Manufacturing, LLC·Product code DPS·December 18, 2024

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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