BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1

    FDA 510(k)
    FDA Class 2 ·Immunology

    AcceleDent Aura

    FDA 510(k)
    FDA Class 2 ·Dental

    High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·July 2, 2021

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 6, 2014

    AXIOM LUMINOS DRF

    FDA Adverse Event
    Injury ·SIEMENS AG·Product code MQB·August 20, 2012

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·September 21, 2010

    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