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

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    IVEX-2 EXTENSION SET WITH Y-INJECTION SITE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122949·K-WIRE - SINGLE TROCAR 1.6mm DIA x 200mm

    Overjet Charting Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    JUSHA-C33C LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JDI·December 15, 2016

    COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 17, 2017

    COBALT CHROME FEMORAL HEAD

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 21, 2012

    ARDIS PEEK IMPLANT 08X09X22

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE·Product code MAX·December 10, 2010

    CODMAN DISPOSABLE PERFORATOR

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF·Product code HBF·July 17, 2014

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017

    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