BEUDAMED
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    ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EPIONE RoboKit

    FDA UDI
    QUANTUM SURGICAL·03760305400260·The EPIONE® RoboKit™ is used during the CT guid...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036026707·

    RADIONICS LUMBOPERITONEAL SHUNT

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO ARTOSCAN M

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCOS 18X150MM SPL TPR DIST HA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·December 7, 2016

    ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY 60MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·December 7, 2016

    ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 10, 2017

    ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY / TYPE 1 TAPER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 10, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013

    PANORAMA CENTRAL STATION WITH TEMEMETRY

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·August 18, 2014

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·May 4, 2011

    ARCOS DISTAL SCREW TI DIA5X50MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·October 12, 2016

    ARCOS DISTAL SCREW TI DIA5X45MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·October 12, 2016

    ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY TYPE 1 TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 14, 2017

    ARCOS MODULAR REVISION HIP

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code KWA·February 16, 2017

    ARCOS STS DISTAL STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 23, 2017

    ARCOS MODULAR REVISION HIP SYSTEM STANDARD BROACH PROXIMAL BODY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·January 6, 2017

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

    ARCOS CON SZ A STD 50MM HA 0MM SZ A

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 26, 2021