BEUDAMED
    68 results · 13ms · Sources: EU EUDAMED, US FDA

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    IOLMaster 700

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl-Zeiss-Promenade 10 Jena Germany·Product code HJO·December 7, 2020

    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

    Optimus Fixed Awl

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016

    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·January 21, 2015

    Optimus Fixed Awl

    FDA Recall
    Terminated ·Amendia, Inc·Product code OVD·November 22, 2016

    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 Recall
    Terminated ·Ebi, Llc·Product code OVE·November 11, 2014

    PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    FDA Enforcement
    Class II ·Terminated·Valorem Surgical LLC·August 16, 2017

    Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·January 21, 2015

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·July 18, 2007

    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·July 18, 2007

    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·December 30, 2015

    PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.

    FDA Recall
    Terminated ·Abbott Spine·Product code NKB·April 17, 2008

    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·July 26, 2017

    Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·November 20, 2013

    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    EZ-DOP, diagnostic ultrasound imaging system

    FDA Recall
    Terminated ·DWL Systems, Inc.·Product code IYN·January 5, 2004

    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014

    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    FDA Recall
    Terminated ·MWT Materials, Inc.·Product code LNH·October 6, 2014