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

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    SQA, SPERM QUALITY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673143·LEVAMED STABILI-TRI ANK SUP BLU L II

    G-aenial™

    FDA UDI
    Gc America Inc.·D0470123521·G-aenial Univ. Injectable Unitip A4

    CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    T-SLING

    FDA Adverse Event
    Injury ·HERNIAMESH S.R.L.·Product code PAH·March 7, 2013

    INTEGRIS ALLURA 9 (BIPLANE)

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 1, 2011

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·February 12, 2008

    ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025

    ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025

    ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025

    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019