5 results
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26ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication
FDA Enforcement
Class II
·Terminated·Orthofix, Inc·September 20, 2017
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024