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

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    VIRTUOST

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750004782·LARG QUEST MASK/HG GRN22ID SWL

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837045913·Large Spacer Caddy

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304433649·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776164881·Crile Retractor [ and ]

    MEDITRON II THESTERTHOSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOBILEDIAGNOST WDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATTUNE FB TIB BASE SZ 3 CEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 1, 2019

    SJM EPIC STENTED PORCINE HEART VALVE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·May 10, 2013

    TPS UNIDIRECTIONAL FOOTSWITCH

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·September 24, 2014

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 2, 2011

    IMP TM 4.1MM MTX FULL, 11.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·May 13, 2022

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025