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

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    Omnichroma Flow Bulk

    FDA 510(k)
    FDA Class 2 ·Dental

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133517·LATERAL,STEMMED INSERTABLE

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133500·LATERAL,STEMMED INSERTABLE

    DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPEN SPINE CLAMP, TITANIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 27, 2014

    KAPPA 700 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·July 3, 2013

    6VT-D PROBE

    FDA Adverse Event
    Injury ·GE VINGMED ULTRASOUND AS·Product code ITX·August 18, 2017

    TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·May 5, 2020

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021