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

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    Plasma IQ

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

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357232222·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688045747·

    ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12

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

    PERLA TL Posterior Osteosynthesis System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·May 22, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 26, 2013

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·June 29, 2016

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 4, 2014

    VISIV

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code KPE·August 9, 2011

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 12, 2013

    SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DWC·June 14, 2018

    IFUSE IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·SI-BONE, INC.·Product code OUR·September 29, 2020

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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