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

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    Platinum dRF Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004411·Activation Wire, 52mm

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376666204·12mm Core Active Lock Driver Long

    Rumex

    FDA UDI
    RUMEX INTERNATIONAL CORP.·00840159907658·Corneal Trephine Blades, 6.50 mm, Stainless Steel

    BioHorizons

    FDA UDI
    BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002879·One-piece/Overdenture Surgical Tray w/Lid

    TIBIAL INSERT IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS, INC.·Product code OOG·April 28, 2017

    Orthocryl®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011160301000·Orthocryl® EQ powder, clear/ orthodontic acrylics

    OPAL BOND FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    PALOMAR LUX1540 HANDPIECE

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

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·June 30, 2021

    BD MICRO-FINE¿+ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 28, 2022

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2013

    CARESCAPE MONITOR B850

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·April 28, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020

    Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

    FDA Recall
    Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 27, 2020

    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

    FDA Enforcement
    Class II ·Terminated·Elana, Inc.·December 14, 2016

    Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream

    FDA Enforcement
    Class II ·Terminated·Thayer Medical Corporation·February 15, 2017