BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    DORSAL NAIL PLATE, ANATOMICAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Plum

    FDA UDI
    ICU Medical, Inc.·10887787007715·ColorGard LATEX-FREE MIDLENGTH SECONDARY I.V. S...

    CHASE CARDIOVASCULAR PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DINAMAP PRO 1000 MONITOR, MODEL 1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 4, 2013

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·May 23, 2008

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·DEGANIA SILICON LTD.·Product code KOG·April 12, 2011

    CYSTO , Model No SACY80R

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

    FDA Enforcement
    Class II ·Terminated·Vision Rt Inc·December 3, 2014

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·November 14, 2012

    ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Green striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 40522-48.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014