BEUDAMED
    29 results · 19ms · Sources: EU EUDAMED, US FDA

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    Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Channel Medsystems, Inc.·April 23, 2025

    Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Channel Medsystems, Inc.·May 29, 2024

    The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.

    FDA Enforcement
    Class II ·Ongoing·STANLEY BLACK & DECKER INC.·January 8, 2020

    Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

    FDA Enforcement
    Class II ·Ongoing·New Medical Technologies Gmbh·February 12, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·May 10, 2023

    GE Heathcare Giraffe OmniBed; neo natal incubator

    FDA Enforcement
    Class I ·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024

    NEO DELTA SELFSAFE PUR T, I.V. Catheter:

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    NEO DELTA Self Safe, I.V. Catheter REF 3738222

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 14, 2025

    NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 16, 2022

    GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

    FDA Enforcement
    Class I ·Ongoing·DATEX--OHMEDA, INC.·October 23, 2024

    NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    FDA Enforcement
    Class I ·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·October 9, 2024

    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Enforcement
    Class I ·Ongoing·SonarMed Inc·April 24, 2024

    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Enforcement
    Class I ·Ongoing·SonarMed Inc·April 24, 2024

    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

    FDA Enforcement
    Class I ·Ongoing·SonarMed Inc·April 24, 2024

    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

    FDA Enforcement
    Class II ·Ongoing·Delta Med SpA·August 25, 2021