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

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    ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Straumann Sterile Healing Solution

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLAR PUREFIX HA SHOULDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRK·March 3, 2014

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code LRK·March 29, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2013

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 28, 2010

    UNKNOWN HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·July 28, 2014

    AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRK·November 30, 2015

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 24, 2025

    AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code LRK·October 2, 2015

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021