BEUDAMED
    66 results · 31ms · Sources: EU EUDAMED, US FDA

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    SMAXEL CO2 Surgical Laser System

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

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327115048·FLUOROSCOPY SOFTWARE 2.3 CD

    Drill Block

    FDA UDI
    I.T.S. GmbH·09120047297247·Drill Block, Left, Distal Femur Plate

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004831·36 x 50mm Mesh Plate

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694065184·1.6 System 36 x 50mm Mesh Sterile Qty 1

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

    FX 222-02 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE ECSCOPE 12I

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

    FDA Enforcement
    Class II ·Terminated·Capso Vision, Inc.·May 27, 2020

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023

    GM HELIX IMPLANT 6.0X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

    GM HELIX ACQUA IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    3DKNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code OIY·June 13, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 27, 2011

    GM HELIX IMPLANT 6.0X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER® Smart Mini