BEUDAMED
    2,836 results · 29ms · Sources: EU EUDAMED, US FDA

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    NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.

    FDA Enforcement
    Class II ·Terminated·Baylis Medical Company Inc.·May 27, 2020

    Trexo Device

    FDA Enforcement
    Class II ·Ongoing·Trexo Robotics Holdings Inc.·August 2, 2023

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class III ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017

    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

    FDA Enforcement
    Class II ·Terminated·Pdg Product Design Group Inc·October 1, 2014

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017

    Navitrack System - OS Knee Universal, Stereotaxic instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017

    Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017

    NDI P7 Position Sensor, Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017

    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017

    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

    FDA Enforcement
    Class II ·Terminated·O-Two Medical Technologies, Inc.·August 29, 2018

    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Health Sciences Canada, Inc.·December 5, 2018

    e600 Automatic Transport Ventilator, Model Number 01EVE600

    FDA Enforcement
    Class I ·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019

    e500 Automatic Transport Ventilator, Model Number 01EVE500

    FDA Enforcement
    Class I ·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019

    e700 Automatic Transport Ventilator, Model Number 01EVE700

    FDA Enforcement
    Class I ·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019

    NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

    FDA Enforcement
    Class II ·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022