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

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    Cepheid Xpert Respiratory Control Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Jawz Endomyocardial Biopsy Forceps

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333206841·Jawz Endomyocardial Biopsy Forceps 7F x 105cm S...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127284·Apex Revision Knee System-Common Instruments Pan

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306821790·Laryngeal Mirror #6

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195009·Apex Revision Knee System-Common Instruments Pa...

    CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IFS PROFILE PLATES, SCREWS, AND WASHERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KNT·November 10, 2021

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 21, 2014

    COROX OTW-L 85-BP

    FDA Adverse Event
    Malfunction ·BIOTRONIK, SE & CO KG·Product code NKE·June 29, 2011

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012