BEUDAMED
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    C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032897·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm B...

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    TITANIUM MIDDLE EAR PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

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

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·November 12, 2024

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·November 12, 2024

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·April 3, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 29, 2011

    SOLUSET VENTED 100 X 60

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD·Product code FPA·April 23, 2008

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    BD CONNECTA STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 11, 2020

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024