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

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    Smith & Nephew ACCORD™ Cable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024039889·

    DURALOC

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295106807·DURALOC SCREW-IN TRIAL LINER 28mm ID 62mm OD 10...

    Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    ITOTAL G2

    FDA Adverse Event
    Injury ·CONFORMIS, INC.·Product code JWH·October 30, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·July 10, 2013

    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

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025