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

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    Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.

    FDA Enforcement
    Class II ·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·May 1, 2024

    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Enforcement
    Class II ·Ongoing·Koven Technology, Inc.·April 1, 2026

    Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

    FDA Enforcement
    Class II ·Ongoing·LimFlow, Inc.·February 4, 2026

    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

    FDA Enforcement
    Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026

    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

    FDA Enforcement
    Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026

    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

    FDA Enforcement
    Class II ·Ongoing·SEASPINE ORTHOPEDICS CORPORATION·May 1, 2024

    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024