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

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    Syntec Non-Sterile Steinmann Pins System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

    10PW - Georgia Body Fluid

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588009339·10PW - Georgia Body Fluid

    MIKULICZ RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896100770·MIKULICZ RETRACTOR

    CONSENSUS CS2 PLUS ACETABULAR INSERT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GARAVENTA SUPER-TRAC TRE-52

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    ETHERNET CAT5 TO FIBER CONV.

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·April 12, 2017

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    STANDARD STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·June 14, 2013

    CORDLESS DRIVER 2 HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HRX·July 1, 2011

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·March 16, 2017

    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·December 27, 2017

    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·September 26, 2018

    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

    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