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

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    INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

    FDA 510(k)
    FDA Class 2 ·Radiology

    SM30 EMERGENCY MEDICAL KIT

    FDA UDI
    HF ACQUISITION CO. LLC·00850065007076·

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023403·MUCOSOL (Cleland's Reagent) 15x10ml

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003437·Jacobson Needle Holder

    Minit®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333369·

    Zavation

    FDA UDI
    Zavation LLC·00842166120853·Spinous Process Plate Assembly 35mmx10mm

    DATA COMM II LAB MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·AVL SCIENTIFIC CORP.·Product code CHL·December 24, 1996

    ART-M1, MODEL M1-1-ART-A1

    FDA 510(k)
    FDA Class 2 ·Dental

    OS-2000 OPTICAL SONOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INSYTE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·September 17, 2024

    STANDARD INSERTION HANDLE

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

    HANGER

    FDA Adverse Event
    Injury ·HANGER·Product code FXZ·February 18, 2011

    RELIANCE 444 WASHER/DISINFECTOR

    FDA Adverse Event
    Other ·STERIS CANADA CORPORATION·Product code FLE·December 28, 2007

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    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

    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