BEUDAMED
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    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

    FDA Enforcement
    Class II ·Terminated·Parker Medical·July 27, 2016

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Enforcement
    Class II ·Terminated·SCM True Air Technologies LLC·May 28, 2014

    JK Bariatric Beds, True Air Technologies, Inc.

    FDA Recall
    Terminated ·SCM True Air Technologies LLC·Product code OSI·March 18, 2014

    Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011

    SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 25, 2014

    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code 000·May 7, 2012

    Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code FJK·December 10, 2007

    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Gambro Renal Products, Inc.·Product code FJK·May 2, 2008

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJK·February 27, 2015

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010

    Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FJK·April 14, 2021

    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

    FDA Recall
    Terminated ·Nipro Medical Corporation·Product code FJK·December 19, 2017

    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FJK·April 17, 2020

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FJK·November 19, 2010

    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.

    FDA Recall
    Terminated ·Axcentria Pharmaceuticals, LLC·Product code EJK·June 5, 2014

    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code FJK·December 9, 2013

    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FJK·April 17, 2020

    NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.

    FDA Recall
    Terminated ·Nipro Medical Corporation·Product code FJK·March 30, 2015