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

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    MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RMO

    FDA UDI
    Rmo, Inc.·00885797099884·IMPRES TRAY KIT MX/MN ASST 30

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023106·AFB Base Decontamination Reagent (3.0%)

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508103028·Non-Cannulated Tap-Straight Flute 5.5mm

    ACCUWELL TSH, MODEL KAW-TSH-960

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GETTIG GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPINDLE ASSEMBLY FOR TRIAL

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·February 28, 2013

    OT PING METER

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

    ACCU-CHEK COMPACT TEST DRUM

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

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; 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