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

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    MOBILETT Elara Max

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026

    MOBILETT ELARA MAX

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020

    ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SL3

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    IMPL TAPERED SP 3.7MM 12M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    VERSYS FEMORAL STEM BEADED FULLCOAT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LPH·July 5, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

    bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021