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

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    Edge Upper Cervical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221307150·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221307000·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1676221307070·

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004260·Luna Opal R Mini .022 UL3 D/HK (0°T +11°A)

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551074473·Ear Forceps,curved upwards, 8 cm

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G22312213070·Drysdale Nucleus Manipulator Paddle Shaped Tip,...

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    VisCalor

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 24, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·November 3, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code NKM·March 25, 2024

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022

    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