BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    JETi AIO Peripheral Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 20, 2023

    ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·July 25, 2023

    ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·July 25, 2023

    CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 30, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 16, 2011

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 9, 2013

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018