BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746122927·DB BKT MINI MS UR CUSP 018 T=0 A+8 R=0

    GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LVM QUALITY CONTROL SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·July 10, 2015

    ISOFLEX P

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 1, 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