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

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    OLYMPIC INFA-LENGTH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    General

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087975·Cutting Tip, Non-Cannulated

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981202446·Interbody, 9mm x 32mm x 11mm, 20 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981194451·Interbody, 9mm x 32mm x 11mm, 20 deg

    R&G Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LASIK

    FDA Adverse Event
    Injury ·Product code LZS·January 21, 2013

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·December 17, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2014

    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