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

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    12SL ECG ANALYSIS PROGRAM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2026

    PLEURX LOCKABLE DRAINAGE LINE SET

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·September 26, 2025

    PLEURX

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code DWM·June 2, 2025

    ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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