BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

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    Spectra S3 Plus

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

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583030005·EXPRESSFIT PRO 2017.1

    MASTERGRAFT PUTTY

    FDA 510(k)
    FDA Class 2 ·Dental

    MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUWAVE, VAMP PLUS

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

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·April 3, 2019

    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

    TRUWAVE, VAMP PLUS

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

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 6, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 28, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 30, 2008

    TRUWAVE, VAMP PLUS

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

    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    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

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    SECURESTRAP UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GDW·April 3, 2019