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

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    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿ King LTS-D" Supraglottic Airway.

    FDA Enforcement
    Class II ·Terminated·Bound Tree Medical·July 15, 2020

    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DRY·September 30, 2020

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    FDA Enforcement
    Class II ·Terminated·Besmed Health Business Corporation·October 24, 2018

    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    FDA Recall
    Terminated ·Besmed Health Business Corporation No.5, Lane 116, Wu-Kong 2nd Road Wu-Ku District New Taipei City Taiwan·Product code CAE·August 9, 2018

    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu King LTS-D" Supraglottic Airway.

    FDA Recall
    Terminated ·Bound Tree Medical·Product code CAE·May 14, 2020

    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.

    FDA Enforcement
    Class II ·Terminated·Ambu Inc.·March 30, 2016

    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·November 18, 2020

    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.

    FDA Recall
    Terminated ·Ambu Inc.·Product code BTO·February 10, 2016

    Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular·March 17, 2021

    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

    FDA Enforcement
    Class II ·Terminated·Medtronic Vascular·March 17, 2021

    Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·January 15, 2021

    Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30

    FDA Recall
    Terminated ·Medtronic Vascular·Product code DQY·January 15, 2021

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    FDA Enforcement
    Class II ·Terminated·HF Acquisition Co. LLC·August 19, 2020

    CATH.GUIDE 8F EBU 5.0 SH 110CM CATHETER LA8EBU50SHA LA 8F 110CM EB50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU50SHA

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU45A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH.GUIDE 8F EBU 4.0 110CM CATHETER LA8EBU40SHA LA 8F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU40SHA

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006