BEUDAMED
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    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

    FDA Recall
    Terminated ·GETINGE US SALES LLC·Product code DXG·June 5, 2019

    Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969

    FDA Recall
    Terminated ·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004

    Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.

    FDA Recall
    Terminated ·Talladium Inc·Product code EBG·October 9, 2020

    Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·June 25, 2010

    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DXG·February 14, 2020

    icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DXG·November 9, 2020

    AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.

    FDA Enforcement
    Class II ·Terminated·AESDEX·July 25, 2018

    Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 10, 2016

    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·February 10, 2016

    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

    FDA Recall
    Terminated ·Trinity Sterile, Inc.·Product code OXQ·February 23, 2021

    AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.

    FDA Recall
    Terminated ·AESDEX·Product code FZP·April 2, 2018

    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·May 13, 2014

    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OWB·November 3, 2015

    Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OWB·November 3, 2015

    Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018

    Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·October 31, 2018

    ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Conmed Corporation·May 15, 2019

    ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Conmed Corporation·May 15, 2019