BEUDAMED
    76 results · 27ms · Sources: EU EUDAMED, US FDA

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    EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925018495·FARRIOR INSTRUMENT CASE STAINLESS STEEL

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1304390·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450356852·

    HEADFIX

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDIWORKS SLIT LAMP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SILK SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAP·January 10, 2019

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·September 30, 2014

    5.0 INTERNAL CAPTURE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWC·June 16, 2011

    INSPIRE 6F

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

    Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·April 1, 2026

    RESERVOIR INSPIRE 8

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·April 1, 2026

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

    INSPIRE HARD VENOUS RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

    INSPIRE HVR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022