BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EK DELIVERY DEVICE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OMNIPOD 5 POD

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·June 1, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 3, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Death ·INSULET CORPORATION·Product code LZG·July 19, 2023

    NEUROFORM 3 STENT SYSTEM

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code NJE·October 23, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 15, 2011

    2124215-2013-09993

    FDA Adverse Event
    Malfunction ·GUIDANT PUERTO RICO BV·Product code NVY·July 8, 2013

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·December 13, 2023

    OMNIPOD DASH, PODS 10-PACK

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·May 9, 2023

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 23, 2024

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 21, 2022

    OMNIPOD 5 POD

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·July 11, 2023

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·April 17, 2023

    StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020