BEUDAMED
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    BOD POD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70608481·BioQuick-Brackets McLaugh/Benn/Trev. .018" 100 ...

    LASER ENGINEERING, INC.

    FDA registration
    LASER ENGINEERING, INC.·1 product·🇺🇸 United States

    NAFD 100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    VISIONWIRE

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DQX·April 16, 2013

    WECK HEM-O-LOK CLIPS, MEDIUM-LARGE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·March 11, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 6, 2014

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    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