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

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    3880 MRI Patient Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AOS HUMERAL NAIL 8.0mm x 20cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016895·

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100837·FLIERINGA FIXATION RING 22MM

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702453188·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...

    Sentinel

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522123184·SENTINEL 10 TEST SYSTEM, STAND ALONE (ENG)

    STIMLAB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTEGRITY MODEL 1014284

    FDA 510(k)
    FDA Class 2 ·Radiology

    BARD PCA PUMP

    FDA Adverse Event
    Injury ·BARD MEDSYSTEMS DIV. C.R. BARD, INC.·Product code MEA·January 2, 1996

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 8, 2016

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 29, 2020

    NITINOL REAMER SHAFTS WITH AO COUPLING

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code HTO·May 11, 2017

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 24, 2013

    GREENLIGHT XPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 15, 2011

    STERLING MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DQY·September 18, 2008

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 28, 2020

    DELTA CERAMIC OPTION HEAD DIA3 6

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·April 18, 2018

    Allura Xper FD20/15; Model Numbers: 722058; 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

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019