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

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    NNC GOLD ABUTMENT FOR BRIDGES

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304554078·

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00887868267567·

    SimplyGo Mini

    FDA UDI
    Respironics, Inc.·00606959033818·SimplyGo Mini, IKK

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003921·75 V2 MED 22ID STRAIGHT NO HG

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 7, 2019

    ARTISTE SOLUTION WITH SYS_VB50 UPDATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACS 180 HOMOCYSTEINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

    FDA Enforcement
    Class II ·Ongoing·ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY·March 26, 2025

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·May 7, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL·Product code MKJ·May 24, 2011

    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

    FDA Recall
    Open, Classified ·ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland·Product code MBF·March 3, 2025

    Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    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