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

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    CLEARFIL SA PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169677661·SPACER 5021427 CONTROL PTC 18 DEG 14X27

    CAPSTONE CONTROL™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169108912·SPACER 4021427 18 DEG 14X27

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310214273·FG Diamond 850-012 round end taper regular 5/pack

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120214271·Carbide, egg, finishing bur

    MBI PD-103 SL; MBI PD-103 SH

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007

    VANGUARD CR ILOK FEM-RT 70

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 26, 2013

    HUDSON NEBULIZER W/TEE & TUBING SMALL VOLUME

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·February 8, 2011

    Calix P PEEK Lumbar System, PLIF Trial

    FDA Enforcement
    Class II ·Terminated·X Spine Systems Inc·October 26, 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

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017