BEUDAMED
    23 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Enforcement
    Class II ·Terminated·Wilson-Cook Medical Inc.·February 6, 2019

    Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product

    FDA Enforcement
    Class II ·Ongoing·Medtronic Sofamor Danek USA Inc·April 12, 2023

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

    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