BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    MAX PULSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034990·Interstitial Ovoid (right) 35mm 15°, R12,5

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 2, 2015

    IMPLANT, FIXATION DEVICE CONDYLAR PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 20, 2023

    AAXTER A3 POSTERIOR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SONOSITE HAND-CARRIED ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    THE EMAX 2 PLUS SYSTEM

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 23, 2014

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·April 25, 2011

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024