BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    TITAN REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    Ortho Development Corporation·00822409116836·Starter Broach

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694003230·1.6mm Pre-bent Plate, 4mm step, Left

    RaPET® CRP

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001240·Latex agglutination slide test for the Qualitat...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175740·Z-Rod, Dia. 6.0mm, Titanium, 50mm

    NA

    FDA UDI
    STRYKER CORPORATION·04546540995575·6.4mm Inverted Cone

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064057·1.6 OSA 4mm Pre-bent Left Plate Sterile Qty 2

    TORAYSULFONE DIALYZER, BS-L SERIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    R & D SYSTEMS XERET HEMATOLOGY CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CAPIOX®FX

    FDA Adverse Event
    Death ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 27, 2025

    INTELLAMAP ORION¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DRF·February 18, 2016

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 24, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·June 16, 2011

    *

    FDA Adverse Event
    Other ·FAUSTINO RINCON·Product code HXK·October 5, 2007

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015