BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    DANMAR PRODUCTS MICHIGAN CRANIAL HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAMLOG

    FDA UDI
    Preat Corporation·00842092103395·CAMLOG® Screw-Line-compatible 6.0mm Engaging Ve...

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159008838·Micro Kitzmiller Clamp

    GentleYAG 3MM Delivery System W/O DCD

    FDA UDI
    Candela Corporation·00817495022352·Delivery System Assembly

    MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KSEA BIPOLAR COAGULATING ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFINION? PRO

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 6, 2026

    VERCISE? CARTESIA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·September 12, 2025

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 8, 2013

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·February 23, 2011

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE-2.5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·February 15, 2008

    CFR74, 12X100 KII OPT ADVFIX HDL 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 8, 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

    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