BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    McLaren Proton Therapy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    X-CORE

    FDA UDI
    Nuvasive, Inc.·00887517424273·X-CORE 2 Ti Core, Ø16x37-63mm

    HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEGACY ABUTMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    ENDOVIVE® SAFETY PEG KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·September 16, 2008

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 12, 2020

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·July 19, 2019

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·August 14, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 30, 2020

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 28, 2020

    OHICHO3

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 26, 2018

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    OHICHO3

    FDA Adverse Event
    Injury ·Product code LIT·September 17, 2019

    MAGNETOM Verio Dot. Model Number: 10684333.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014