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

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    Peristeen Anal Irrigation System

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584052358·JU9 ITED, WL L BE JUNA 9

    ESI GloSpec

    FDA UDI
    FTT MEDICAL, INC.·B3961403100·Single use vaginal speculum with built in light...

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649439·INTREPED 10 Sizer

    microdot® Pro Gloves

    FDA UDI
    Cambridge Sensors USA LLC·00847713000954·microdot® Pro Nitrile Large Gloves

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981179830·Z-Rod, Dia. 6.0mm, Co-Cr, 310mm

    NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Truliant

    FDA UDI
    Exactech, Inc.·10885862315076·Truliant CR Porous Femoral

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 26, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 17, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code MXC·January 13, 2014

    MINI-CAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 31, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 15, 2011

    Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008

    FDA Enforcement
    Class II ·Terminated·Banyan Medical, LLC·October 19, 2016

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·October 9, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·COVIDIEN (IRVINE)·Product code OUT·August 11, 2015

    UNKNOWN CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·December 5, 2024