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

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    iPulse Smooth Skin Gold Hair Removal System

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169631786·COBB 2143003 OLIF25 DOUBLE SIDED 20MM

    V. Mueller

    FDA UDI
    STERIS CORPORATION·10885403279249·V. Mueller DISPOSABLE BIPOLAR FORCEPS

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180188723·RUBBER BALL ONLY FOR ELLIK EVACUATOR

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613022440·Blakesley Forceps, Size 2, 4.5 x 11mm Cup Jaws

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011613·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 3

    AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    TCM40 MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    COREVALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 4, 2014

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·May 30, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·September 27, 2011

    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

    FDA Enforcement
    Class II ·Ongoing·Abbott·November 8, 2023

    PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    OmniDiagnost Eleva System codes 708028 708027

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020