BEUDAMED
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    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code EZX·October 7, 2015

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015

    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Fujinon Endoscope Series; Model # EPX-4400 and EPX-4400HD. Digital processing of images from endoscope.

    FDA Recall
    Terminated ·Fujinon Inc·January 7, 2011

    Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015

    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·April 13, 2022

    Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x

    FDA Recall
    Terminated ·Philips Healthcare·Product code OWB·February 2, 2022

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 21, 2016

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·August 24, 2016

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

    Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code KGB·November 11, 2020

    Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

    FDA Enforcement
    Class II ·Terminated·Westmed, Inc.·January 6, 2021

    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code MUJ·September 28, 2015

    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·November 7, 2018

    First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009