BEUDAMED
    51 results · 21ms · Sources: EU EUDAMED, US FDA

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    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code KWQ·November 20, 2015

    ZVU Functional GI Software, REF: ZVU-3

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

    Multitom RAX with software version VF10

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021

    AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

    Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

    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 Recall
    Terminated ·Ebi, Llc·Product code LXH·August 13, 2013

    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 Recall
    Terminated ·Ebi, Llc·Product code HWC·August 22, 2013

    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 Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054

    FDA Recall
    Terminated ·Ebi, Llc·Product code NKB·September 16, 2010

    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·September 29, 2012

    48" Lead Wires, Replacement Part Number: 1067724-4

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024

    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 Recall
    Terminated ·Ebi, Llc·Product code HXX·February 7, 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 Recall
    Terminated ·Ebi, Llc·Product code HXX·September 24, 2013

    20" Lead Wires, Replacement Part Number: 1067724-2

    FDA Recall
    Open, Classified ·EBI, LLC·Product code LOF·March 22, 2024