BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Passport Series Patient Monitors (Including Passport 8, Passport 12)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111075636·SKLHN OP SCIS CVD SS SER 5 1/2

    BRIVO XR385

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOGRAPH MCT FAMILY

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVN·June 8, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 5, 2008

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023