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

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    Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Flow sensor

    FDA UDI
    Hamilton Medical AG·07630002802840·Flow sensor for use with all HAMILTON ventilato...

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·November 14, 2002

    Gridlock Ankle Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KLS MARTIN RIGID FIXATION - STERILE

    FDA 510(k)
    FDA Class 2 ·Dental

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 18, 2002

    Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

    FDA Enforcement
    Class II ·Terminated·Hamilton Medical, Inc.·July 8, 2015

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 26, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·November 18, 2014

    BED, MANUAL

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNJ·August 1, 2013

    Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.

    FDA Recall
    Terminated ·Hamilton Medical, Inc.·Product code BZO·June 1, 2015

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology