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

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    MODIFIED DISPOSABLE FETAL VACUUM

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

    LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M MODEL 8245 ITE HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 12, 2014

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 29, 2010

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    FDA Adverse Event
    Other ·MEDTRONIC, INC.·Product code NEK·January 10, 2013

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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