BEUDAMED
    13 results · 25ms · 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.
    Filters Regulation: Us FDA ×

    CytoSure Urinary Access System

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

    ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOLCART B

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

    RADIUS-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 2, 2015

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 3, 2013

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 26, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 5, 2014

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014