BEUDAMED
    82 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·February 25, 2015

    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·February 25, 2015

    Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·August 1, 2012

    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·March 17, 2021

    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics·October 29, 2014

    Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38.5¿C (89.6¿F to 101.3¿F) in adult and pediatric patients of all ages.

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·August 1, 2018

    Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·August 1, 2012

    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.

    FDA Enforcement
    Class II ·Terminated·Revmedx Inc·September 23, 2015

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·March 25, 2015

    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, PowerLoc Port Access Kit 22G x 0.75in, , PowerLoc Port Access Kit 19G x 1 in with Y-Site, , , PowerLoc Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Port Access Kit 20G x 1 in with Y-Site, PowerLoc Port Access Kit 20G x 0.75in with Y-Site The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.

    FDA Enforcement
    Class II ·Terminated·Bard Access Systems·March 25, 2015

    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Sekisui Diagnostics Llc·December 12, 2012

    Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 47116201900 COMPRESSION SCREW 1/2IN 47116202300 COMPRESSION SCREW 1-1/2IN 47116202200 COMPRESSION SCREW 1-1/4IN 47116202400 COMPRESSION SCREW 1-3/4IN 47116202100 COMPRESSION SCREW 1IN 47116202000 COMPRESSION SCREW 3/4IN Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·June 1, 2022

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734. Usage: Infusion of solution/medication into implanted intravascular ports.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·June 1, 2016

    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017

    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 20, 2017