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

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    UNI-T UNI-THREAD SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PAQ.215X280X300/QT.HS80/CASE-12.1P GREEN

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763090496·

    Woven Phillips Follower Urethral Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741072949·Woven Phillips Follower Urethral Catheter

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038009·TRIAL RASP, TAPERED, 10MM X 22MM

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00811801035258·Rib Derotation Set -Transverse Connector

    OS-2000 OPTICAL SONOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MULTI HI-FLO PNEU, WISAP #7080

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FCG·September 7, 2021

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 26, 2013

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·February 16, 2011

    ACCU-CHEK SPIRIT CARTRIDGE

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·March 26, 2008

    XPS® HANDPIECE - UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·October 17, 2017

    HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·October 28, 2021

    EGIA 45 ARTICULATING MED/THICK SULU

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014