BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    ICE PACK, REUSABLE FLEXIBLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ReLine

    FDA UDI
    Nuvasive, Inc.·00887517010476·RELINE-C Handle, Small Fixed

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989050813·UPPER RIGHT FIRST MOLAR TRIMLINE BAND SIZE 9

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189800·AK3 Femoral Impactor Pad

    Continuum® Trilogy® Allofit® Longevity®

    FDA UDI
    Zimmer, Inc.·00889024152267·

    Continuum® Trilogy® Allofit® Longevity®

    FDA UDI
    Zimmer, Inc.·00889024152281·

    Continuum® Trilogy® Allofit® Longevity®

    FDA UDI
    Zimmer, Inc.·00889024152274·

    THD SLIDE ONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

    FDA 510(k)
    FDA Class 2 ·Neurology

    M2A-38 CUP NON FLARED SZ 60MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 5, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 15, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·August 2, 2010

    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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