BEUDAMED
    15 results · 20ms · 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 ×

    FINGERTIP PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zavation

    FDA UDI
    Zavation LLC·00842166176706·MIS Tap

    Zavation

    FDA UDI
    Zavation LLC·00842166176713·MIS Tap

    Zavation

    FDA UDI
    Zavation LLC·00842166176683·MIS Tap

    Zavation

    FDA UDI
    Zavation LLC·00842166176690·MIS Tap

    MIRAGE VISTA MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PTA-DUO PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMISTEM H HA COATED STD STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2022

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPS1

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GCJ·May 21, 2013

    PACEART SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DPS·June 16, 2011

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025