BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    SENSOR WALK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704921048·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284904·WILTSE GELPI RETRACTOR 11"

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809846492·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776294076·Wiltse Gelpi Retractor

    TWIN FIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX

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

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code GEI·December 22, 2009

    BILATERAL DOUBLE BALLOON SET

    FDA Adverse Event
    Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006

    LIVIAN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 13, 2011

    SILICONE ADVANCED OPTIC LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·May 23, 2008

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS,INC·Product code BZD·October 18, 2021

    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

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

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024