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

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    AVID-NIT LOSS OF RESISTANCE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00173011·

    Scanlan® PrepMARK

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159025392·Scanlan® PrepMARK - Reg Tip, Gentian Violet, No...

    Cortera Spinal Fixation System

    FDA UDI
    Xtant Medical Holdings, Inc.·00840311252305·ROD BENDER, CORONAL, 6.0, RIGHT

    NA

    FDA UDI
    aap Implantate AG·04042409048128·K-wire with trocar point, ø1.7, L 310

    URANUS, COMFORTOUCH LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973448·

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 25, 2022

    VERCISE? CARTESIA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·January 2, 2026

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011

    ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·February 19, 2008

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·October 3, 2018

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 23, 2023

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024