BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    Adler MicroMed Laser Surgery Fibers

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

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055530·

    VARIOUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCOPEVALET DISPOSABLE BIOPSY VALVE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·June 3, 2019

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 22, 2011

    SYMBIQ DCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 3, 2014

    1.5 LACTOSORB SYSTEM STRAIGHT PLATE - 8 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·November 2, 2020

    1.5 LACTOSORB SYSTEM CURVED PLATE - 6 HOLE

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·November 2, 2020

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·July 24, 2019

    TIBIAL INSERT FB SZ 3 RT 10MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·April 13, 2023

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

    VANTAGE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSN·March 25, 2019

    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code MCW·October 31, 2016

    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corporation·December 7, 2016

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023