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

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    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.

    FDA Recall
    Terminated ·Medical Action Industries, Inc.·Product code OWL·October 12, 2022

    PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.

    FDA Recall
    Terminated ·Access Scientific LLC·Product code OWL·June 15, 2020

    PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.

    FDA Recall
    Terminated ·Vygon U.S.A.·Product code OWL·February 28, 2018

    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

    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

    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

    Optimus Fixed Awl

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

    Optimus Fixed Awl

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

    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 Recall
    Terminated ·Biomet Spine, LLC·Product code OVD·August 22, 2013

    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

    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