BEUDAMED
    25 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Terminated × Clear all

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.

    FDA Enforcement
    Class I ·Terminated·Hummingbird Med·July 13, 2016

    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

    FDA Enforcement
    Class I ·Terminated·Hummingbird Med·June 1, 2016

    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    FDA Enforcement
    Class I ·Terminated·NOXBOX LTD·June 21, 2023

    ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers

    FDA Enforcement
    Class I ·Terminated·Flexicare Medical Ltd.·December 2, 2020

    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, Ltd.·August 19, 2015

    Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.

    FDA Enforcement
    Class I ·Terminated·Event Medical LTD·November 25, 2015

    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, Ltd.·December 2, 2015

    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician

    FDA Enforcement
    Class I ·Terminated·Spacelabs Healthcare, Ltd.·November 29, 2017

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

    FDA Enforcement
    Class I ·Terminated·Spacelabs Healthcare, Ltd.·August 22, 2018

    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, LTD.·October 31, 2018

    Quantum Pump Console

    FDA Enforcement
    Class I ·Terminated·Spectrum Medical Ltd.·September 4, 2019

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    FDA Enforcement
    Class I ·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013

    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013

    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013