BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    BIOMIC VIDEO PLATE READER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981194499·Interbody, 9mm x 32mm x 12mm, 20 deg

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981202484·Interbody, 9mm x 32mm x 12mm, 20 deg

    AUDIT MICROCONTROLS MICROFD BNP CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    KESTREL POSTERIOR CERVICAL SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 3, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·December 17, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 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