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

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    Opticross 35 15 MHz Peripheral Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

    Waterlase Laser Tips

    FDA UDI
    Biolase, Inc.·00647529001097·A tip kit containing 20 single-use MZ Zip tips...

    MAYO LEXER SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083868·MAYO LEXER SCISSORS DELICATE STRAIGHT POWER CUT...

    QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PVS 1500 SDS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 6, 2008

    CLS SPOTORNO, EXPANSION SHELL, UNCEMENTED, ø 58

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 5, 2025

    TALENT STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·February 2, 2012

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 24, 2014

    ACETABULAR AUGMENT

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code LPH·July 26, 2011

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 1, 2013

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020