BEUDAMED
    17 results · 34ms · Sources: EU EUDAMED, US FDA

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    HELENA HBA2 QUIK COLUMN METHOD

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·EINO8031089·Locking bow for open stereotactic headring, cer...

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·04250307606085·Locking bow for open stereotactic headring, cer...

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978035192·INSTRUMENT 803-108 GUIDEWIRE INSERTER

    BD PHASEAL¿ INJECTOR LUER LOCK N35J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code LHI·October 30, 2018

    BASHAW CERVICAL IMMOBILIZER DEVICE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Ignite Stemless Anatomic Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MAV·October 24, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·August 31, 2007

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 9, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023