BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLYMETHYLMETHACRYLATE BONE CEMENT

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code NDN·August 16, 2016

    NA

    FDA UDI
    Conmed Corporation·30653405002141·ELECTROSURGICAL FOOTSWITCH

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013322·SHEA VEIN PRESS

    CONMED

    FDA UDI
    Conmed Corporation·20653405002144·ELECTROSURGICAL FOOTSWITCH

    ArgenZ ST 98x12 ML C1B

    FDA UDI
    ARGEN CORPORATION, THE·D818130146·Dental porcelain/ceramic restoration kit

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450185261·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197540117·Caspar Rongeur straigth 6x16mm 140mm

    EVOLVE EPS ORTHOLOC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+

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

    COBAS 6000 CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 16, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 20, 2017

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code IXR·May 21, 2013

    BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DRC·September 30, 2014

    SIGMA 100 VVI

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015