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

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    AAP CANNULATED SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780811·LEVAMED ACTIVE ANKLE SUP SLVR R III

    Vatech Clismile

    FDA UDI
    Rayence Co., Ltd.·08800018601419·This product is an orthodontic bracket and is u...

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854007037·ULTRAPOWER BUR, ROUND (MUSTARD) 10 MM

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112330·Tap, 5.50mm, Fixed Sleeve

    MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·March 24, 2013

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·March 16, 2011

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 28, 2008

    SARS-COV-2 IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code QKO·November 23, 2021

    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·February 4, 2015

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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