BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636676·CoRoent Ant TLIF PEEK, 12x13x34mm 15°

    ArgenZ ST 98x12 ML B2

    FDA UDI
    ARGEN CORPORATION, THE·D818123345·Dental porcelain/ceramic restoration kit

    ATRAMAT

    FDA UDI
    Internacional Farmacéutica, S.A. de C.V.·07500142063756·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...

    ATRAMAT

    FDA UDI
    Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970508·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970577·

    HONOUR SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 26, 2014

    ICON 25 HCG (COMBO CASSETTE)

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·June 10, 2011

    THREE PEG PATELLA 41MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 26, 2025

    UNITIP CATHETER FOR HR GI

    FDA Adverse Event
    Malfunction ·UNISENSOR USA INC·Product code FFX·January 16, 2015

    BAIR HUGGER / 3M

    FDA Adverse Event
    Injury ·3M·Product code DWJ·November 23, 2016

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 1, 2024

    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 Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    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