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

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    Electrodes Handpieces for Mygen V-1000 RF System

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

    Contrast Line

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207398·Contrast Line 20"(50cm) Female/Rotating Adapter...

    Healthweigh

    FDA UDI
    Rice Lake Weighing Systems, Inc.·00850042373149·Scale,Floor Level 160-10-7N 550lb(250kg) x 0.2l...

    GDC 360 DETEACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    PCR ELEVA 1.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    MAXIMO II

    FDA Adverse Event
    MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT·Product code NIK·July 7, 2011

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 7, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013

    NEXTAR INFRARED CAMERA

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

    PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

    Pulmonary Valve & Conduit SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code NPT·February 12, 2014

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 22, 2013

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023