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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    UNO Negative Pressure Wound Therapy System

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

    PIN SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RVT CTO DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 11, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 14, 2011

    ATTAIN PERFORMA

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·October 10, 2014

    TREVO XP PROVUE RETRIEVER 4X30

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    TREVO XP PROVUE RETRIEVER 4X20

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    TREVO XP PROVUE RETRIEVER 4X20

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    TREVO XP PROVUE RETRIEVER 3X20

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    TREVO XP PROVUE RETRIEVER 3X20

    FDA Adverse Event
    Death ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    TREVO XP PROVUE RETRIEVER 3X20

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·November 8, 2016

    Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

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