332 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories·April 3, 2024
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
FDA Enforcement
Class II
·Terminated·Ebi, Llc·November 27, 2013
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·December 31, 2014
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
FDA Enforcement
Class II
·Terminated·Ebi, Llc·December 26, 2012
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·October 9, 2013
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·June 25, 2014
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·March 27, 2013
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
FDA Enforcement
Class II
·Terminated·Ebi, Llc·December 4, 2013
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
FDA Enforcement
Class II
·Terminated·Ebi, Llc·January 14, 2015
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
FDA Enforcement
Class II
·Terminated·Ebi, Llc·September 25, 2013
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 10, 2014
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 15, 2015
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012