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

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    LigaSure Curved, Small Jaw, Open Sealer/Divider

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    Modular Stick

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040666·

    CRAG LATERAL FLOW ASSAY (CRAG LFA)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEUTSCH ANTI-BLOCKAGE WOUND DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEM INC.·Product code LZG·February 18, 2011

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 7, 2013

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·July 7, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    NOVOFINE PLUS 4MM (32G)

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MS HJOERRING·Product code FMI·January 22, 2021

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012