BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004

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

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    TRUWAVE, VAMP PLUS

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    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

    BABY RX05 OXY W/ HR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 14, 2013

    DIAMONDBACK 360 ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·CARDIOVASCULAR SYSTEMS, INC·Product code MCW·July 22, 2011

    ACCOLADE (127 DEG)

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·September 30, 2008

    TRUWAVE, VAMP PLUS

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

    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

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024