BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    E-BEAM ND: YAG LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HARDYCHROM MRSA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HARMONY INR MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVIA CENTAUR CP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 14, 2011

    IVT DIPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·May 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 8, 2016

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015