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

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    ENTERAL FEEDING TUBE

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051480·VENERE 30, SIZE M, MIELE, GRADUATED COMPRESSION...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981173371·L Con, Side-Loading, L, 8mm, 480mm

    AURECAST 40 B

    FDA 510(k)
    FDA Class 2 ·Dental

    VIVA

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

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 10, 2013

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·May 21, 2008

    URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 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

    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