BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PARADIGM INTERSPINOUS FUSION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LUMAX 640 VR-T DX PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·June 27, 2013

    O.B. SUPER PLUS NON-APPLICATOR

    FDA Adverse Event
    Malfunction ·MONTREAL SAN PRO·Product code HEB·July 13, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 20, 2014

    RHYTHMIA HDX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 25, 2019

    HANDLE ACETABULAR PRESS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    ACETABULAR PRESSURIZER SMALL

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    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