BEUDAMED
    27 results · 23ms · Sources: EU EUDAMED, US FDA

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    GMK Sphere & GMK SpheriKA Cementless

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK SPHERE CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105442·GLOBAL C.A.P. CTA CTA HEAD TRIAL 48 x 18

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105459·GLOBAL C.A.P. CTA CTA HEAD TRIAL 48 x 21

    GLOBAL CAP CTA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295105466·GLOBAL C.A.P. CTA CUTTING BLOCK SIZE 48

    THE ARTAS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 25, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 4, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 12, 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