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

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    Renuvion® APR Handpiece

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

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780142904·Integra® Jarit® Smith-Petersen Laminectomy Rong...

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464029174·OTICON MORE 1 MINIRITE T C063

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540177285·BIPOLAR FORCEPS

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020638·INTRG WHISP-Z MBT 2BIC HK -17T 0A 018 LL

    devemed

    FDA UDI
    devemed GmbH·04061644024711·Anatomical tweezers, micro TC, 1.3 mm, straight...

    Terragene Chemdye

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLAT PANEL DISPLAY, ME183L

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    1.8MM UNIVERSAL VARIABLE ANGLE LOCKING DRILL GUIDE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 10, 2019

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 13, 2008

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013

    8.5MM PLATFORM FX STEM RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·April 17, 2023

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    AxioGlass

    FDA UDI
    Axiodent Inc.·D161230270·

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015