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

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    AION TempShield™

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025364·Performance Pro Flex Nitrile Exam Glove Small, ...

    Reddick-Saye Screw Retractor

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101979·Reddick-Saye Screw Retractor Kit, 4 pack, eIFU

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785113383·

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931178·BIT, TREPHINE 4.0MM 1/4 SQ

    CERAMAGE

    FDA 510(k)
    FDA Class 2 ·Dental

    Apogee

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Injury ·BETA BIONICS, INC.·Product code QFG·April 27, 2026

    MEDLINE

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FPA·March 3, 2026

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·December 3, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 26, 2013

    MEDLINE

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FPA·March 3, 2026

    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.

    FDA Enforcement
    Class I ·Ongoing·Elekta Instrument AB·April 24, 2024

    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·February 17, 2021

    60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·February 17, 2021

    154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·February 17, 2021

    60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·February 17, 2021

    20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130; (01)10887709069203(17)250401(30)50(10)4803158; (01)10887709069203(17)250101(30)50(10)4558617; (01)10887709069203(17)250101(30)50(10)4589967. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 28, 2020