BEUDAMED
    27 results · 31ms · Sources: EU EUDAMED, US FDA

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    PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013847·Zirlux 16+ B2 98.5X18

    IMPACT-PLUS

    FDA UDI
    Denplus Inc·D8451011116·IMMPACT-PLUS, ORI, 454 g

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED

    INSET 30

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 20, 2025

    PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

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

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 9, 2025

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 24, 2025

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    QUANTUM¿ MAVERICK¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 19, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 8, 2011

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    SURGE CARDIOVASCULAR

    FDA Adverse Event
    Malfunction ·SURGE CARDIOVASCULAR·Product code GCX·March 31, 2017

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 14, 2017

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·May 22, 2018