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

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    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048305006·STRAIGHT FRONT PIECE

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002140·artVeneer life upper posteriors, XL, D3

    SoftTip® small

    FDA UDI
    Honeywell Healthcare Solutions GmbH·04036616009836·SoftTip® klein RS-2414-30 HP/Philips

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159026276·Vascular Clamp with 12 mm Jaw

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167900021400·

    OPEL-L

    FDA UDI
    SpineArt SA·07640332477199·OPEL-L PLATE ASSEMBLY, L40

    CURE OPEL-L (S)

    FDA UDI
    MEDITECH SPINE, LLC·B167S1900021400·

    CLINI-DENT

    FDA 510(k)
    FDA Class 1 ·Dental

    IDS5 IMAGE DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD SYRINGE 5ML LS EMERALD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 24, 2020

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    2520274-2013-10209

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code MNI·February 11, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 4, 2011

    PUMP MMT-515LNAL PRDGM INS V2.1 CL EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·February 25, 2008

    SMOKE EVACUATOR RF SENSOR

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code FYD·February 2, 2023

    SYRINGE 5ML LS EMERALD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 1, 2021

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012