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

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    FORA V10 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311217060·

    Cervical Interbody 17mm x 13.5mm x 6mm Packaging

    FDA UDI
    XENCO MEDICAL LLC·B064XM11217061·Cervical Interbody 17mm x 13.5mm x 6mm

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321217060·

    CancelleX™ 17mm x 13.5mm x 6mm Cervical Interbody

    FDA UDI
    XENCO MEDICAL LLC·B064XM3D31217061·

    BD SAFETYGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·April 12, 2018

    VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HORIZONS HOT BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 25, 2025

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 13, 2014

    AMIS BROACH HANDLE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 8, 2013

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 13, 2011

    INCLUSIVE TAPERED IMPLANT

    FDA Adverse Event
    Malfunction ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 17, 2018

    NEEDLE SFTYGLD 21X1-1/2 RB TW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·May 30, 2019

    Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQX·May 30, 2006

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018