BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158212930·SCISSOR REYNOLDS CURVED FINE 6"

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180185166·OPERATING SCISSORS, FINE, REYNOLDS, CURVED, 15CM

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471121942·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 125mm

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981194468·Interbody, 9mm x 32mm x 11mm, 15 deg

    General

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087999·Punch

    WaveForm TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981243623·Interbody, 9mm x 32mm x 11mm, 15 Deg, 3D

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981202453·Interbody, 9mm x 32mm x 11mm, 15 deg

    ABSOLUTE DENTIN 2

    FDA 510(k)
    FDA Class 2 ·Dental

    NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCU-CHEK SPIRIT

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 1, 2014

    APEX OVER-THE-WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·December 17, 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