BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SureFISH MYC BA P200

    FDA UDI
    AGILENT TECHNOLOGIES, INC.·05700574008895·SureFISH MYC BA P200

    CONCORDE CURVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS 4800 CT / NG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MAGELLAN HYPODERMIC SAFETY NEEDLE 25 G X 5/8 INCHES

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code FMI·September 21, 2021

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 23, 2014

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-ASAHI·Product code DQX·June 2, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·August 8, 2008

    SAFETY NEEDLE 25 X 5 8

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FMI·December 28, 2021

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The cobas¿¿ PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas¿¿ CT/NG Test. - The cobas¿¿ PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas¿¿ CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas¿¿ PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas¿¿ CT/NG Test.

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·March 5, 2014

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021