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

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    Filters Regulation: Us FDA ×

    Prelude SNAP Splittable Hydrophilic Sheath Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI TORQUE CONNECT GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECOLAB

    FDA Adverse Event
    ECOLAB·Product code LHC·January 21, 2016

    ECOLAB

    FDA Adverse Event
    ECOLAB·Product code LHC·January 21, 2016

    ECOLAB

    FDA Adverse Event
    ECOLAB·Product code LHC·January 21, 2016

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 3, 2014

    ZIMMER MIS HIP HYBRID OFFSET SHELL INSERTER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·June 28, 2011

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·February 12, 2016

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024