BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159570·PROTECT.GENU KNEE SUPPORT GRAY II

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 18, 2015

    VISUM LED SURGICAL LIGHTING SYSTEM

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

    Infrared Forehead Thermometer, FT-100A

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 2, 2012

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 12, 2013

    IMP,TSV,4.1,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·May 22, 2023

    IMP,TSV,4.1,8,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·April 26, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 9, 2024

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 26, 2013

    COULTER ACT DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 22, 2011

    JOHNSON & JOHNSON FLOSS, WAXED

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code JES·November 19, 2014

    PFC SIGMARP STB TB IN 6 12.5

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code NJL·August 2, 2013

    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 8, 2017

    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018