BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Quantum LB

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI-GLOBE ROTA-CUT SPHINCTEROTOME

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

    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

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

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    TRUWAVE VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 19, 2018

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

    VIRTUOSO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    GMK SPHERE TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 3, 2017

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

    TRUWAVE, VAMP PLUS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026