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

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    Diode laser device (BM091)

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

    NITREX™

    FDA UDI
    EV3, INC·00763000185466·GW N251801 NITREX V04

    NITREX

    FDA UDI
    Covidien LP·00821684058220·Guidewire

    NITREX

    FDA UDI
    Covidien LP·10821684009113·Guidewire

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709046276·9" (23 cm) Appx 1.3 ml, Bifuse Ext Set w/2 Micr...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756029230·Needle Counter

    Arc Endocuff Vision

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

    Rapid Acoustic Pulse Device

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 30, 2024

    9" BIFUSE EXT. SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·January 19, 2016

    VANGUARD SSK 360 FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·April 10, 2018

    VANGUARD SSK 360 FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JWH·April 10, 2018

    BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTZ·August 3, 2022

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·November 14, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 31, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2013

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, 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 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 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

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