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

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    MAXILLARY DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159022773·Puskas™ Jacobson Micro Needle Holder

    THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    NOVA CORDLESS CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    PROSTHESIS, HIP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·November 11, 2021

    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    iQ Waste Well Adapter, Part Number: 700-3393

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code LKM·December 19, 2023

    GRAPHIC CASE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA) MONUMENT·Product code LXH·February 28, 2013

    ASKU

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 1, 2011

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIO·February 20, 2008

    iQ Waste Well Adapter, Part Number: 700-3393

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 31, 2024

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 1, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024