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

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    Conometric Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020

    SYNTHES HEMOSTATIC BONE PUTTY

    FDA 510(k)
    FDA Unclassified ·Unknown

    QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    BD ULTRA-FINE III PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 31, 2021

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    SCRDRIVER SHAFT T25 F/UNI-SCR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·June 21, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·July 28, 2011

    PEN NDL 31GA 8MM 100 BX 1200 LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 26, 2020

    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 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

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, 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 Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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