BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    FCP-9P, FIBER CHOLEDOCHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221116796·3M™ Victory Series™ First Molar Bands, 953-286,...

    MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    iHealth Align Gluco-Monitoring system

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENPULSE

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·February 9, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

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

    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