BEUDAMED
    96 results · 23ms · Sources: EU EUDAMED, US FDA

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    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare·February 15, 2017

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·August 8, 2018

    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·November 7, 2012

    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare·January 20, 2016

    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

    FDA Enforcement
    Class II ·Terminated·Harvest Technologies Corporation·October 23, 2013

    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·October 2, 2019

    MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 20, 2016

    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 20, 2016

    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·November 28, 2012

    MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·November 28, 2012

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    FDA Recall
    Terminated ·Tornier, Inc·Product code KWS·May 28, 2021

    PET Infusion Pump

    FDA Recall
    Terminated ·Bayer Healthcare·Product code FRN·September 30, 2016

    ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

    FDA Enforcement
    Class III ·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 12, 2014

    The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·August 29, 2012

    ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.

    FDA Enforcement
    Class II ·Terminated·Horiba Instruments, Inc dba Horiba Medical·March 12, 2014

    Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.

    FDA Recall
    Terminated ·Bayer Healthcare·Product code FRN·November 30, 2015

    Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008

    Physio-Control LIFEPAK 20 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code LDD·April 16, 2008