BEUDAMED
    26 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Philips C9-5EC Transducer.

    FDA Enforcement
    Class II ·Ongoing·Philips Ultrasound, Inc·July 9, 2025

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 22, 2025

    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·October 2, 2024

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    FDA Enforcement
    Class II ·Ongoing·Fisher & Paykel Healthcare, Ltd.·May 22, 2024

    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

    FDA Enforcement
    Class II ·Ongoing·Adept Medical Ltd·January 29, 2025

    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

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·September 7, 2022

    Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 29, 2022

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    FDA Enforcement
    Class II ·Ongoing·New Standard Device Inc·June 21, 2023

    OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024