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

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    QUANTA LITE ACA SCREEN (HRP)

    FDA 510(k)
    FDA Class 2 ·Immunology

    SICAT OPTISLEEP

    FDA 510(k)
    FDA Class 2 ·Dental

    FERRITIN CALIBRATOR SET, CATALOG NO. 8203

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    ADEPT

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - VIENNA·Product code MCN·January 7, 2011

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 23, 2014

    4K C-MNT SCP,4.0,30,167,MITEK

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL·Product code HRX·November 5, 2025

    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 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