BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464032365·SONIC RADIANT 100 MNR T TP

    Ocu-Film® +"

    FDA UDI
    REICHERT, INC.·00812559012485·

    Ocu-Film +

    FDA UDI
    REICHERT, INC.·00812559012096·Single use tonometer tip cover used with Tono-P...

    ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU

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

    SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS

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

    I-STAT

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·April 21, 2023

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 6, 2014

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·August 12, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ITI·July 16, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025