BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRU® NP Healing Abutment .050" Hex, 3.0 mmm, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549107856·Healing Abutments are intended for placement on...

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010836·Fixed, 4 electrode, RVA, 5mm electrode spacing

    SPEEDFIX SUTURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENSITE 3000 SYSTEM, MODEL EE3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 30, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013

    NATURAL-KNEE II CONGRUENT TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·November 11, 2010

    ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 17, 2020

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    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