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

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    Grappler Suture Anchor R3FLEX IOL System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADWELL DISPOSABLE PROBE HANDLE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STORM TDX POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    4.5 VA CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 19, 2013

    PERISTEEN BAG/RECTAL CATHETERS

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code KNT·August 25, 2011

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·August 5, 2014

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026