BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    SYNTHES SYNMESH SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vital Signs

    FDA UDI
    Carefusion Finland 320 Oy·10885403269165·300-Series ECG Leadwire, Individual Replacement...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023755·QC1 Gram Negative Slide

    DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RETCAM II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 15, 2024

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

    ZENITH AAA MAIN BODY GRAFT

    FDA Adverse Event
    Injury ·COOK INCORPORATED·Product code MIH·February 27, 2008

    NUVASIVE HELIX ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

    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