BEUDAMED
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    FISTULOK FISTULA NEEDLE PROTECTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 15, 2021

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH

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

    OPRA IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·INTEGRUM AB·Product code PJY·December 8, 2023

    ARTERIAL CANNULA

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code DWF·March 15, 2013

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·March 4, 2011

    AV PLUS DX BIFURCATED BIPOLAR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·June 12, 2013

    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 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