BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Tablo Hemodialysis System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216027900·ANATOMIC PEEK w/ Nano 14 x 11 x 7 x 10°

    Brophy Tissue Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896122758·Brophy Tissue Forceps Tungsten Carbide Serrated...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034692·Low Profile Plate Holder / #9 Woodson Elevator

    Waterlase Laser Tips

    FDA UDI
    Biolase, Inc.·00647529000977·A reusable fiberoptic accessory intended for us...

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code JSG·October 2, 2023

    EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNICONDYLAR KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 27, 2022

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    VANGUARD FEM PEGS SET 2

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 24, 2014

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code DHA·July 1, 2013

    CRAGG-MCNAMARA

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·May 4, 2022

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 19, 2019

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021