BEUDAMED
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    Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code MFC·June 22, 2009

    Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code ODW·February 25, 2008

    Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019

    Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).

    FDA Recall
    Terminated ·Dow Corning Corp.·September 5, 2003

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·December 21, 2016

    bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 1, 2013

    MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.

    FDA Recall
    Terminated ·Biocardia, Inc.·Product code DYB·February 7, 2014

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code DSZ·December 5, 2012

    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 17, 2020

    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 17, 2020

    Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code GDW·November 25, 2003

    Endopath EZ45 Endoscopic Linear Cutter (ET45B).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code GDW·November 21, 2004

    Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear Cutter, product code i45; Intelligent 45mm Articulating Endoscopic Linear Cutter, Vascular, product code i45V.

    FDA Recall
    Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

    Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC.

    FDA Recall
    Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

    Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4.

    FDA Recall
    Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

    Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

    FDA Recall
    Terminated ·Product code GDW·August 21, 2012

    Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S

    FDA Recall
    Terminated ·United States Surgical·Product code GDW·May 5, 2004