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

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    OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

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

    COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES

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

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    ADEPT ADHESION REDUCTION SOLUTION

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

    RIATA ACTIVE FIXATION

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

    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