BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    7D Surgical System - Percutaneous Application (7D Flash Frame)

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707022497·CALIBRA BANDS 2ND MOLAR n.SUR 22

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134392·LATERAL,RONGEUR,PITUITARY,4

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517076790·

    MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AERO CHROME* Breathable Performance Surgical Gowns

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

    NONE

    FDA Adverse Event
    Other ·STAAR SURGICAL CO.·Product code HQL·October 29, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·July 2, 2025