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

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    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 16, 2019

    Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·May 6, 2005

    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017

    LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11235-03

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·September 29, 2005

    HoverMatt Patient Transfer Solution/Air Transfer Mattress

    FDA Recall
    Terminated ·D.T. Davis Enterprises Ltd.·Product code FRZ·September 13, 2005

    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    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

    1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    FDA Recall
    Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 9, 2017

    Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·February 13, 2008

    Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·January 10, 2008