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

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    0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

    FDA Adverse Event
    Death ·BECTON DICKINSON·Product code FOZ·April 1, 2016

    UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FOZ·March 4, 2016

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040007860·Zirlux 16+ C4 89x17x10

    TRI-LOCK HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TPO IGG ANTIBODY EIA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 3, 2018

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 10, 2011

    MAXID 23/40 W / SH KIT W/VT

    FDA Adverse Event
    Other ·TYCO HEALTHCARE/KENDALL·Product code MSD·March 11, 2008

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019