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

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    GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051794·CHANTAL LACE 70, SIZE M, CHAMPAGNE, GRADUATED C...

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XLTEK LED GOGGLES, MODEL LED-01

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    SPRINT QUATTRO

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

    LACTOSORB SCREW 1.5X4MM 1.5 SYSTEM, 10 PACK

    FDA Adverse Event
    Other ·BIOMET MICROFIXATION·Product code MAI·May 28, 2008

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    VUELOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VUELOCK PLATE, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    VEULOCK SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    EXTRACTION SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·March 19, 2018

    EXTRACTION SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·April 4, 2013

    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