BEUDAMED
    11 results · 21ms · 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 ×

    AIRVO HUMIDIFIER MYAIRO HUMIDIFIER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ArgenZ HT+ 98x10 A3.5

    FDA UDI
    ARGEN CORPORATION, THE·D818121975·Dental porcelain/ceramic restoration kit

    LASERSYSTEM BEAUTYSTAR 532

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

    CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

    FDA 510(k)
    FDA Class 2 ·Dental

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Injury ·B.BRAUN SURGICAL SA·Product code MPN·July 23, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 13, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 13, 2008

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015