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

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    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006410·2200A 2WAY Y 10.5MMOD/7.5MMID

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741124350·

    AOS TIBIAL NAIL 12mm x 43.5cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016383·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674112435060·

    ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BEYONDIMAGE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    ACTIVA

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code MHY·April 5, 2016

    M2A-TAPER LINER SZ 41/32

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·May 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 28, 2011

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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