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

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    7.0 FR. ENDOBRONCHIAL BLOCKER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Safco FG Composhape Finishing Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310219203·FG Diamond 379-022 football fine (red) 5/pack

    Embla

    FDA UDI
    XLTEK·00382830047241·NATUS EMBLA SDx

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776177768·HEGAR DILATOR

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG

    EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    WAKO AUTOKIT LP(A)/ RA,500/1000,

    FDA 510(k)
    FDA Class 2 ·Immunology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    TITAN OTR

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FHW·December 29, 2020

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code PZE·December 2, 2021

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 26, 2013

    SHUNT SENSOR SYS500

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 7, 2011

    PULMONETIC

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 203/ PULMONETIC SYSTEMS, INC.·Product code CBK·March 28, 2008

    ARNDT ENDOBRONCHIAL BLOCKER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code CBI·October 24, 2017

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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