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

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    KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Paxeon Femoral Head

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570200252·Paxeon Head, Ceramic Size 40mm XL

    Signature Femoral Head

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215002039·

    OrthoMedFlex, LLC

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111526440·Ceramic Femoral Head, 40mm +8mm (XL)

    BD¿ PEN NEEDLE STERILE SINGLE USE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·April 26, 2018

    ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

    FDA 510(k)
    FDA Class 2 ·Hematology

    SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIGNATURE Head - BIOLOX Delta

    FDA UDI
    AMPLITUDE SAS·03701089520867·

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·June 5, 2013

    COLLEAGUE PRE 1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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