BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    CLEAR ALIGNER ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517564856·CoRoent Ant TLIF PEEK, 12x13x34mm 8°

    ArgenZ ST 98x12 ML B3

    FDA UDI
    ARGEN CORPORATION, THE·D818123348·Dental porcelain/ceramic restoration kit

    Logical G-Series Acetabular Shell

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215052102·

    Paxeon Logical

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570201242·Logical G-Series Shell – 3 Holes Size 48-B

    Logical G-Series

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215000851·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111233480·48mm Acetabular Cup (3-hole)

    DIGIVIEW 250

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIDMARK M9 ULTRACLAVE STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VENTO Cup

    FDA UDI
    AMPLITUDE SAS·03701089514033·

    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

    INRATIO

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

    NOVATION

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·November 5, 2019

    THREE PEG PATELLA 41MM

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

    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