BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Medtronic Patient Asistant

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120496·Guidewire 1.1x150mm Sgl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120472·Guidewire 1.1x150mm Dbl Trocar

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053937·ORTHOS ACCENT LFM OSGL NDX -10TX22 L

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111603·Modular Stem 11mm x 75mm

    LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 14, 2014

    DELTAFILL18 8MM X 35CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·July 29, 2020

    STERILE DRAPE SLEEVES

    FDA Adverse Event
    Malfunction ·FHC, INC.·Product code MMP·August 28, 2014

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    AJUST HELICAL SINGLE-INCISION SLING

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code PAH·May 31, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 29, 2008

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024