BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M MODEL 8242 ITE HEARING AID

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

    MONARCH STERILIZATION CONTAINER SYST, MODIFICATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TERUMO ADVANCED PERFUSION SYSTEM 1

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

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

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

    TECNIS MULTIFOCAL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·December 6, 2010

    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