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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843828·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE EXTRA ...

    Arx

    FDA UDI
    Life Spine, Inc.·00190837124472·

    Arx

    FDA UDI
    Life Spine, Inc.·00190837130633·

    MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N LATEX CYSTATIN C

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 11, 2013

    1ST RESPONSE RESUSCITATOR, INFANT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC. BY: GALEMED CORPORATION·Product code BTM·May 28, 2008

    CAPSUREFIX NOVUS

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

    CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 8, 2016

    Conformer - Medium (Sterile)

    FDA Recall
    Terminated ·Gulden Ophthalmics·Product code HQX·November 29, 2002

    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