BEUDAMED
    20 results · 34ms · Sources: EU EUDAMED, US FDA

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    LEVANT, HOMEGLIDE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SMARTPIN

    FDA UDI
    Conmed Corporation·10845854015360·SMARTPIN SELF-REINFORCED TECHNOLOGY, Ø1.5 X 60 MM

    SMARTPIN

    FDA UDI
    Conmed Corporation·10845854015367·SMART PIN, DIAMETER 1.5 X 60MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776303754·Taylor Dura Scissors 5.5" with probe tip

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180199859·Cushing dressing forceps. Bayonet. Serrated, sq...

    SafeGuide® Single

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734023334·Disposable Over the Guidewire Esophageal Dilato...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045476·PrimaLIF LLIF PEEK Implant, 15mm X 18mm X 60mm,...

    MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

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

    MEDLINE RETRACTABLE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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

    TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

    UNKNOWN DEPUY ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 21, 2013

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    FDA Adverse Event
    Malfunction ·CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.·Product code KNT·July 29, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 2, 2011

    EGIA 45 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020