BEUDAMED
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    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

    FDA Recall
    Terminated ·Alcon LenSx, Inc. 33 Journey Aliso·Product code OOE·March 14, 2014

    Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·Optimedica Corporation·Product code OOE·February 20, 2015

    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code OOE·February 20, 2015

    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code OOE·April 14, 2016

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018

    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·SIE AG, Surgical Instrument Engineering Allmendstrasse·Product code OOE·January 21, 2018

    Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·Optimedica Corporation·Product code OOE·December 20, 2013

    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

    FDA Enforcement
    Class II ·Terminated·Zoe Medical Incorporated·September 26, 2012

    Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

    FDA Recall
    Terminated ·Cook Inc.·Product code KOE·January 4, 2019

    SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LOE·February 19, 2018

    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Recall
    Terminated ·EBI Patient Care, Inc.·Product code LOE·April 20, 2017

    EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LOE·February 19, 2018

    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    FDA Recall
    Terminated ·EBI Patient Care, Inc.·Product code LOE·April 20, 2017

    Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code KOE·August 1, 2005

    Urethral Dilator Set, Global Product No. G14185

    FDA Recall
    Terminated ·Cook Inc.·Product code KOE·January 4, 2019

    The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.

    FDA Recall
    Terminated ·Zoe Medical Incorporated·Product code DXN·February 2, 2009

    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.

    FDA Recall
    Terminated ·Zoe Medical Incorporated·Product code MHX·June 6, 2012

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012

    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·January 29, 2020

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020