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

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    GENADYNE SPIRO FOAM DRESSING KIT

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

    SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TIGERPAW SYSTEM

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

    PLEURX LOCKABLE DRAINAGE LINE SET

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    PENTA

    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

    PLEURX

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

    BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·May 16, 2019

    PLEURX

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

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·March 10, 2020

    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