BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    DEKA ACE Pump System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    XN CAL PF

    FDA UDI
    SYSMEX CORPORATION·14987562460349·XN CAL PF 1X3.0ML

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330266·The nail is intended for use in the fixation of...

    Fixion Nailing System

    FDA UDI
    CARBOFIX ORTHOPEDICS LTD·07290109330945·The interlocking intramedullary nail is intende...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020404·FPS 3.5mm x 36mm Standard Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074520·FPS 3.5 x 36mm Screw Sterile Qty 2

    MASTERKA 40 MASTERKA 35 MASTERKA 30

    FDA 510(k)
    FDA Unclassified ·Unknown

    EMTRAC; DELPHIN; SEMTRAC 2000 SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·August 16, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 30, 2014

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NIK·July 9, 2013

    LAPIPLASTY 4.0MM FULLY THREADED SCREW

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·March 14, 2025

    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 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, 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

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

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

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025