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

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    I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TAMPONADE UTERINE BALLOON CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·January 14, 2019

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    CLAVICLE PIN ASSEMBLY 2.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDW·May 22, 2008

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014