BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Strep B Carrot Broth One-Step

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776318796·House Cup Forceps

    Bernafon

    FDA UDI
    Bernafon AG·05711584063033·SA5 CIC, V2 BE SAPHIRA 5

    Bausch + Lomb

    FDA UDI
    Bausch & Lomb Incorporated·00757770431816·FCP OVAL CUP HOUSE ANG 15 LT

    JEDMED

    FDA UDI
    JEDMED INSTRUMENT COMPANY·M633341705860·FORCEPS OVAL CUP HOUSE ANG 15 LEFT

    ADVIA CENTAUR VITAMIN D TOTAL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VENUS FREEZE SYSTEM

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

    PUMP, INFUSION

    FDA Adverse Event
    Malfunction ·NULL·Product code FRN·January 26, 2022

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 21, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·September 25, 2014

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    RELION PEN NEEDLES 4MM X 32 GAUGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024