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

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    EECP THERAPY SYSTEM, MODEL TS3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023199·NAC-PAC (4.0%) 5x50ml

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    R&D PROJECT DW269#25

    FDA 510(k)
    FDA Class 2 ·Dental

    RANDOX COMPLEMENT C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    DRIVE SHAFT-MINIMUM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTO·February 28, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 21, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024