BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    ECG-less Cardiac

    FDA 510(k)
    FDA Class 2 ·Radiology

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364841·IdentiTi ALIF SA, T25 Driver, Angled, 40°, Long

    IdentiTi

    FDA UDI
    ALPHATEC SPINE, INC.·00190376364858·IdentiTi ALIF SA, T25 Driver, Angled, 60°, Long

    Straumann CARES P-Series CAD/CAM System

    FDA 510(k)
    FDA Class 2 ·Dental

    OCCLUDER OCCLUSION BALLOON CATHETER

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

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 3, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 18, 2013

    DELTA CERAMIC FEM HD 36/+3MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·June 23, 2023

    36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·June 14, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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