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

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    Fusion Silastic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CETRA

    FDA UDI
    Orthofix US LLC·18257200120376·1-LEVEL PLATE ASSEMBLY, 36MM

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306812118·Virtus Splinter Forceps, Plier Style, 15cm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197193351·Ferreira Style Breast Retractor 190x36...

    STERIS CMAX XLT SURGICAL TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RESPICHAMBER VALVED HOLDING CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISOLATOR TRANSPOLAR PEN

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·April 25, 2007

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·June 18, 2013

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

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