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

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    InBody

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102866·BIPOLAR RF-CABLE WITH LINVATEC / WECK / PILING ...

    Zodiac

    FDA UDI
    ALPHATEC SPINE, INC.·00844856049475·ZODIAC COCR STRAIGHT ROD 5.5 X 60CM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694007078·2.0mm Pilot Drill, Long, Mandible System, J-Latch

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113578·PRESET 600 MICRON KNIFE (BX/5)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694066327·2.4 System 2.0mm Pilot Drill Long J-Latch Steri...

    WORKBENCH BY <GENX>

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

    SYNTHES (USA) RESORBABLE TACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OYC·May 19, 2020

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·August 22, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014