BEUDAMED
    21 results · 39ms · Sources: EU EUDAMED, US FDA

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    Stretta Catheter

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

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055219·

    MODIFICATION TO: STRYKER SPINE OASYS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IQ VENTILATION NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    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

    AQUACEL FOAM ADH 10X10

    FDA Adverse Event
    Malfunction ·CONVATEC INC·Product code NAC·October 2, 2014

    PROTECTA XT DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 7, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011

    CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021