BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFIED HD GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131259660·RIA, MINIBTE 312 WL 85 SGR

    POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COMPLETE D 25-OH VITAMIN D CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 7, 2023

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·October 26, 2018

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 2, 2018

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    COULTER LH 750 SLIDEMAKER ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·June 20, 2011

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 22, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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