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

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    Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014

    FREESTYLE FREEDOM

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

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·July 2, 2013

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018