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

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    I-FUSE HAMMER TOE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLOBAL AP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295005445·GLOBAL AP STANDARD STEM SIZE 6 101mm

    GLOBAL AP

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295005452·GLOBAL AP POROCOAT STANDARD STEM SIZE 6 101mm

    Link OptiStem

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575283101·Modular stem, uncemented, Ti6Al4V, oval

    OIS SYMPHONY IMAGE MANAGMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OVUS CAPLESS SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    MULTIFIRE SCORPION NEEDLE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MDM·May 15, 2013

    FORCE TRIVERSE ES DEVICE COATED BLADE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011

    GE STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 15, 2008

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·December 18, 2013

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 22, 2024

    THREE PEG PATELLA 35MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 24, 2025

    Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of the U.S. only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006