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

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    Tornier Perform Humeral System – Fracture

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916123017·Zeus-P Implant 14 x 9 x 22mm

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916153526·Zeus PLIF, Curved Cage 22mm x 09mm x 14mm

    FLEXITIME FAST & SCAN LIGHT FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

    FDA 510(k)
    FDA Class 2 ·Hematology

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    MINIMED PARADIGM 522 INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·October 31, 2008

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 11, 2013

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

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