BEUDAMED
    26 results · 17ms · Sources: EU EUDAMED, US FDA

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

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    FDA Enforcement
    Class II ·Ongoing·SURGICAL SPECIALTIES·April 24, 2024

    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

    FDA Enforcement
    Class II ·Ongoing·PATH·December 24, 2025

    Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·March 27, 2024

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    FDA Enforcement
    Class II ·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·January 12, 2022

    Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc·January 21, 2026

    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc.·May 12, 2021

    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