BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    TRIMED PLAN, VERSION 2.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...

    ULTRASIM CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIII ALARM AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CC TIBIAL INSERT SZ 3, 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 5, 2023

    SEE H10

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·Product code KWP·November 2, 2021

    XCEL DILATING TIP TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·April 2, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·March 16, 2011

    STARCLOSE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR DEVICES·Product code MGB·March 28, 2008

    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025