BEUDAMED
    79 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 21, 2018

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, C-UDLMY-401J-CCT, G26927, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, C-UTLMY-901J-CCT-RD, G48997, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC-CCT, G26932, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/15cm, C-UQLMY-1001J-CCT, G32392, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMY-701J-CCT-RD, G47815, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-CCT-RD, G47822, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Catheter Tray Five Lumen Polyurethane, 10.0 Fr/ 20cm, C-UQLMY-1001J-RSC-CCT-RD, G51536, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-CCT-RD, G47818, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Catheter Tray, Triple Lumen Polyurethane, 9.0 Fr/ 25cm, C-UTLMY-901J-LSC-CCT-RD, G48998, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    FDA Recall
    Terminated ·Cook Inc.·Product code FOZ·July 31, 2017

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code CCT·March 19, 2018

    LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCT·October 27, 2016

    Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF: LTAD-PL7-25, Lot 121508, packed 25 per package. REF: LTAD-PL7-100, Lot 121508, packed 100 per package. Southmedic 50 alliance Blvd., Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia, 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009

    Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N1-25, Lot 121608, packed 25 per package. REF: LTAD-N1-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009

    Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N3-25, Lot 121608, packed 25 per package. REF: LTAD-N3-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: [email protected] The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia.

    FDA Recall
    Terminated ·Sharn, Inc.·Product code CCT·March 5, 2009

    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCT·July 5, 2017

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code KPS·April 25, 2016

    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·December 7, 2016