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

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    Disposable Temperature Probe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AccuQuest

    FDA UDI
    Bernafon AG·05711584080306·AQ CO7 MNR, 2.4G NFM PB MAC ACCUQ

    PUREFILL OXYGEN COMPRESSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'

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

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM/ ALCON N.V.·Product code KYG·June 17, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 28, 2011

    ADVANTA

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 26, 2008

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 11, 2023

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    LINEAR 7.5 FR. 40CC IAB

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 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