BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Angled Tip Ureteral Catheter

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

    Border-Lock® Upper Tray #44

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015820·Dental impression tray, single-use

    CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO:RADIUS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·February 24, 2009

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    COULTER® AC*T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 21, 2013

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 21, 2011

    ACCU-CHEK COMFORT TEST DRUM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·September 30, 2008

    LINER: CC E CC LIGHT HCT FLAT PE HC LINER Ø 32 / E

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 10, 2019

    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·May 27, 2020

    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

    FDA Recall
    Terminated ·Clinical Innovations, LLC·Product code HDB·August 6, 2019

    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021