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

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    higi Station

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Assured

    FDA UDI
    Dollar Tree Mdsg Chesapeake Ci·00639277288912·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837048730·Expandable Cage Installer Driver

    PATIENT MONITOR, MODEL PM50

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    VAPR COOLPULSE90 ELECTRODE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code GEI·January 24, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 26, 2024

    BD MICROLANCE¿ HYPODERMIC NEEDLE 30G X 0.5"

    FDA Adverse Event
    Injury ·BECTON DICKINSON, S.A.·Product code FMI·August 15, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    HIP HEAD, 10/12 TAPER, 28MM, +0MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 30, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 20, 2018

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·August 8, 2012

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018