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

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    MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS

    FDA 510(k)
    FDA Class 1 ·Dental

    Cohero

    FDA UDI
    MIR MEDICAL INTERNATIONAL RESEARCH SPA·08052990321728·Peak flow and FEV1 meter

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756395915·ARTERIAL DIAGNOSTIC PACK

    Symmetry Rapidclean®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482143681·Glide Lock Tray

    UCR

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080303·CROSSBAR HEX DRIVER

    ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO

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

    MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ANKYLOS C/X IMPLANT

    FDA Adverse Event
    Injury ·FRIADENT GMBH·Product code DZE·January 7, 2013

    0.5ML PATIENT CONTROL MODULEJAPAN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 30, 2010

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024