BEUDAMED
    4 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

    FDA Enforcement
    Class III ·Terminated·Impact Instrumentation, Inc.·August 15, 2012

    X5-1c Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

    FDA Enforcement
    Class III ·Terminated·BC Group International Inc·December 30, 2015